PXP-LAVARE

GUDID 00886368000216

PXP-LAVARE Control Module, packaged

Thermogenesis Corp.

Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit

• Primary Device ID: 00886368000216
• NIH Device Record Key: ce399ea0-359b-4e79-b0b0-e05880f5fc9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PXP-LAVARE
• Version Model Number: 80121
• Company DUNS: 080690327
• Company Name: Thermogenesis Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000179 [Direct Marking]
GS1	00886368000216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120061

FDA Product Code

• OAO: Cord Blood Processing System And Storage Container

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [PXP-LAVARE]

• 00886368000186: PXP-LAVARE Disposable Cartridge
• 00886368000223: PXP-LAVARE Docking Station, packaged
• 00886368000216: PXP-LAVARE Control Module, packaged
• 00886368000209: PXP-LAVARE Disposable Cartridge
• 00886368000193: PXP-LAVARE Disposable Cartridge