COVERA

Basic Information

• Brand Name: COVERA
• Primary DI: 00801741106873
• Version / Model: AVFL06040
• Catalog Number: AVFL06040
• Company Name: Angiomed GmbH & Co. Medizintechnik KG
• Labeler DUNS: 320047483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-01
• Public Version: 5
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: f90bf930-a6b0-48f9-9e4d-715731a56181

Device Description

COVERA™ Vascular Covered Stent 6 mm x 40 mm (120 cm delivery catheter) (flared)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFV	System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61856	Venous endovascular stent-graft	A non-bioabsorbable tubular device designed to be implanted in a central or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis. It is a mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ (e.g., self-expands or balloon-expandable) and disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741106873	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Length, 120 Centimeter
Device Size Text, specify			Implant Diameter, 6 Millimeter
Device Size Text, specify			Implant Length, 40 Millimeter