Vascu-Guard VG0108

GUDID 00085412818498

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

SYNOVIS LIFE TECHNOLOGIES, INC.

Cardiovascular patch, animal-derived

• Primary Device ID: 00085412818498
• NIH Device Record Key: 27f68fad-d6da-42cc-9905-b25fb1b73687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascu-Guard
• Version Model Number: VG0108
• Catalog Number: VG0108
• Company DUNS: 017415781
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +1 800-933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800-933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800-933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412818498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221032

FDA Product Code

• PSQ: Intracardiac Patch Or Pledget, Biologically Derived

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [Vascu-Guard]

• 00085412818634: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi
• 00085412818573: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi
• 00085412818559: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi
• 00085412818535: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi
• 00085412818511: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi
• 00085412818498: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi
• 00085412818474: VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi