Cartilage Biopsy Transport Kit

GUDID 00850037506194

The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)

VERICEL CORPORATION

Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated

• Primary Device ID: 00850037506194
• NIH Device Record Key: 2c5bb754-e2e7-481d-a5e4-eb1135b1bf49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cartilage Biopsy Transport Kit
• Version Model Number: 0
• Company DUNS: 079745570
• Company Name: VERICEL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com
• Phone: (800) 453-6948
• Email: customercare@vcel.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze Cartilage Biopsy Transport Medium or gel packs
• Special Storage Condition, Specify: Between 0 and 0 *Keep gel packs and box with remaining contents at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
• Special Storage Condition, Specify: Between 0 and 0 *Do no expose Cartilage Biopsy Transport Medium to direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850037506194 [Primary]

FDA Product Code

• KDW: Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-10
• Device Publish Date: 2022-12-08

On-Brand Devices [Cartilage Biopsy Transport Kit]

• 00860004093015: The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeon
• 00850037506194: The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeon