Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Enteral feeding bag/bottle FDA UDI
- Device Name
- FARRELL* Valve Closed Enteral Decompression System FDA UDI
- Model / Reference
- 43-4100 FDA UDI
- Description
- FARRELL* Valve Closed Enteral Decompression System FDA UDI
Identifiers
- Catalog Number
- 43-4100 FDA UDI
- Primary DI / UDI-DI
- 00350770461014 FDA UDI
- FDA Product Code
- PIF FDA UDI
- GMDN Term
- Enteral feeding bag/bottle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Enteral feeding bag/bottle
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enteral feeding bag/bottle.
- GR 1200 mL Feeding Bag Set with Enfit Connector — ZEVEX INTERNATIONAL, INC. · Class II
- Infinity Enteral Spike Right Administration Set with Enfit Connector — ZEVEX INTERNATIONAL, INC. · Class II
- Nutri-Clamp — Hospira, Inc. · Class II
- Farrell® -Valve Enteral Gastric Pressure Relief System — Corpak Medsystems · Class II
- Infinity Low Volume Screw Cap Set with Enfit Connector — ZEVEX INTERNATIONAL, INC. · Class II
- Infinity Spike Set with Enfit Connector — ZEVEX INTERNATIONAL, INC. · Class II
- Nutri-Clamp — Hospira, Inc. · Class II
- KBMED — KB Medical (group), Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 8da1a656-4703-4f72-abd7-9d2fc05766ab 35 fields · synced Jun 9, 2026