Identity
- Trade Name
- Angel Catheter FDA UDI
- Generic Name
- Vena cava filter, temporary/permanent FDA UDI
- Device Name
- The Angel® Catheter combines the functions of a retrievable inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). FDA UDI
- Model / Reference
- AC3930A FDA UDI
- Description
- The Angel® Catheter combines the functions of a retrievable inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). FDA UDI
Identifiers
- Primary DI / UDI-DI
- B077AC3930A1 FDA UDI
- FDA Product Code
- PNS FDA UDI
- GMDN Term
- Vena cava filter, temporary/permanent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Centrally-inserted central venous catheterVena cava filter, temporary/permanent
Angel Catheter by Bio2 Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vena cava filter, temporary/permanent.
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- Gunther Tulip — COOK INCORPORATED · Class II
- Gunther Tulip — COOK INCORPORATED · Class II
- ALN Optional Vena Cava Filter - Brachial Approach — A.L.N. · Class II
- Cook Celect — William Cook Europe ApS · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bio2 Medical, Inc.
Sources (1)
- FDA UDI de9ecea1-fcc3-481f-a0d1-efa506aa9031 34 fields · synced May 30, 2026