COVERA AVFM08060

GUDID 00801741106514

COVERA™ Vascular Covered Stent 8 mm x 60 mm (80 cm delivery catheter) (flared)

Angiomed GmbH & Co. Medizintechnik KG

Peripheral venous endovascular stent-graft

• Primary Device ID: 00801741106514
• NIH Device Record Key: ab1ab8c8-e77e-41f5-ac08-26f176ebfaba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COVERA
• Version Model Number: AVFM08060
• Catalog Number: AVFM08060
• Company DUNS: 320047483
• Company Name: Angiomed GmbH & Co. Medizintechnik KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741106514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170042

FDA Product Code

• PFV: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

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: 2019-03-05
• Device Publish Date: 2018-08-01

On-Brand Devices [COVERA]

• 00801741107078: COVERA™ Vascular Covered Stent 10 mm x 100 mm (120 cm delivery catheter) (flared)
• 00801741107061: COVERA™ Vascular Covered Stent 10 mm x 80 mm (120 cm delivery catheter) (flared)
• 00801741107054: COVERA™ Vascular Covered Stent 10 mm x 60 mm (120 cm delivery catheter) (flared)
• 00801741107047: COVERA™ Vascular Covered Stent 10 mm x 40 mm (120 cm delivery catheter) (flared)
• 00801741107030: COVERA™ Vascular Covered Stent 9 mm x 100 mm (120 cm delivery catheter) (flared)
• 00801741107023: COVERA™ Vascular Covered Stent 9 mm x 80 mm (120 cm delivery catheter) (flared)
• 00801741107016: COVERA™ Vascular Covered Stent 9 mm x 60 mm (120 cm delivery catheter) (flared)
• 00801741107009: COVERA™ Vascular Covered Stent 9 mm x 40 mm (120 cm delivery catheter) (flared)
• 00801741106996: COVERA™ Vascular Covered Stent 8 mm x 100 mm (120 cm delivery catheter) (flared)
• 00801741106989: COVERA™ Vascular Covered Stent 8 mm x 80 mm (120 cm delivery catheter) (flared)
• 00801741106972: COVERA™ Vascular Covered Stent 8 mm x 60 mm (120 cm delivery catheter) (flared)
• 00801741106965: COVERA™ Vascular Covered Stent 8 mm x 40 mm (120 cm delivery catheter) (flared)
• 00801741106958: COVERA™ Vascular Covered Stent 7 mm x 100 mm (120 cm delivery catheter) (flared)
• 00801741106941: COVERA™ Vascular Covered Stent 7 mm x 80 mm (120 cm delivery catheter) (flared)
• 00801741106934: COVERA™ Vascular Covered Stent 7 mm x 60 mm (120 cm delivery catheter) (flared)
• 00801741106927: COVERA™ Vascular Covered Stent 7 mm x 40 mm (120 cm delivery catheter) (flared)
• 00801741106910: COVERA™ Vascular Covered Stent 6 mm x 100 mm (120 cm delivery catheter) (flared)
• 00801741106903: COVERA™ Vascular Covered Stent 6 mm x 80 mm (120 cm delivery catheter) (flared)
• 00801741106897: COVERA™ Vascular Covered Stent 6 mm x 60 mm (120 cm delivery catheter) (flared)
• 00801741106873: COVERA™ Vascular Covered Stent 6 mm x 40 mm (120 cm delivery catheter) (flared)
• 00801741106866: COVERA™ Vascular Covered Stent 10 mm x 100 mm (120 cm delivery catheter) (straight)
• 00801741106859: COVERA™ Vascular Covered Stent 10 mm x 80 mm (120 cm delivery catheter) (straight)
• 00801741106842: COVERA™ Vascular Covered Stent 10 mm x 60 mm (120 cm delivery catheter) (straight)
• 00801741106835: COVERA™ Vascular Covered Stent 10 mm x 40 mm (120 cm delivery catheter) (straight)
• 00801741106828: COVERA™ Vascular Covered Stent 10 mm x 30 mm (120 cm delivery catheter) (straight)
• 00801741106811: COVERA™ Vascular Covered Stent 9 mm x 100 mm (120 cm delivery catheter) (straight)
• 00801741106804: COVERA™ Vascular Covered Stent 9 mm x 80 mm (120 cm delivery catheter) (straight)
• 00801741106798: COVERA™ Vascular Covered Stent 9 mm x 60 mm (120 cm delivery catheter) (straight)
• 00801741106781: COVERA™ Vascular Covered Stent 9 mm x 40 mm (120 cm delivery catheter) (straight)
• 00801741106774: COVERA™ Vascular Covered Stent 9 mm x 30 mm (120 cm delivery catheter) (straight)
• 00801741106767: COVERA™ Vascular Covered Stent 8 mm x 100 mm (120 cm delivery catheter) (straight)
• 00801741106750: COVERA™ Vascular Covered Stent 8 mm x 80 mm (120 cm delivery catheter) (straight)
• 00801741106743: COVERA™ Vascular Covered Stent 8 mm x 60 mm (120 cm delivery catheter) (straight)
• 00801741106736: COVERA™ Vascular Covered Stent 8 mm x 40 mm (120 cm delivery catheter) (straight)
• 00801741106729: COVERA™ Vascular Covered Stent 8 mm x 30 mm (120 cm delivery catheter) (straight)
• 00801741106712: COVERA™ Vascular Covered Stent 7 mm x 100 mm (120 cm delivery catheter) (straight)
• 00801741106705: COVERA™ Vascular Covered Stent 7 mm x 80 mm (120 cm delivery catheter) (straight)
• 00801741106699: COVERA™ Vascular Covered Stent 7 mm x 60 mm (120 cm delivery catheter) (straight)
• 00801741106682: COVERA™ Vascular Covered Stent 7 mm x 40 mm (120 cm delivery catheter) (straight)
• 00801741106675: COVERA™ Vascular Covered Stent 7 mm x 30 mm (120 cm delivery catheter) (straight)
• 00801741106668: COVERA™ Vascular Covered Stent 6 mm x 100 mm (120 cm delivery catheter) (straight)
• 00801741106651: COVERA™ Vascular Covered Stent 6 mm x 80 mm (120 cm delivery catheter) (straight)
• 00801741106644: COVERA™ Vascular Covered Stent 6 mm x 60 mm (120 cm delivery catheter) (straight)
• 00801741106637: COVERA™ Vascular Covered Stent 6 mm x 40 mm (120 cm delivery catheter) (straight)
• 00801741106620: COVERA™ Vascular Covered Stent 6 mm x 30 mm (120 cm delivery catheter) (straight)
• 00801741106613: COVERA™ Vascular Covered Stent 10 mm x 100 mm (80 cm delivery catheter) (flared)
• 00801741106606: COVERA™ Vascular Covered Stent 10 mm x 80 mm (80 cm delivery catheter) (flared)
• 00801741106590: COVERA™ Vascular Covered Stent 10 mm x 60 mm (80 cm delivery catheter) (flared)
• 00801741106583: COVERA™ Vascular Covered Stent 10 mm x 40 mm (80 cm delivery catheter) (flared)
• 00801741106576: COVERA™ Vascular Covered Stent 9 mm x 100 mm (80 cm delivery catheter) (flared)