Identity
- Trade Name
- bFed™ FDA UDI
- Generic Name
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
- Device Name
- bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags FDA UDI
- Model / Reference
- SK-2002 FDA UDI
- Description
- bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags FDA UDI
Identifiers
- Catalog Number
- SK-2002 FDA UDI
- Primary DI / UDI-DI
- 00867622000456 FDA UDI
- FDA Product Code
- PIF FDA UDI
- GMDN Term
- Enteral feeding kit, adult/paediatric, non-sterile 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Enteral feeding kit, adult/paediatric, non-sterile
bFed™ by U Deliver Medical L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enteral feeding kit, adult/paediatric, non-sterile.
- AMSure® ENTERAL FEEDING BAG with ATTACHED PUMP MAGNET SET — AMSINO INTERNATIONAL, INC. · Class II
- Plum — Hospira, Inc. · Class II
- Plum — Hospira, Inc. · Class II
- Medline Industries — MEDLINE INDUSTRIES, INC. · Class II
- Medline Industries — MEDLINE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- AMSure® ENTERAL FEEDING BAG with ATTACHED GRAVITY SET — AMSINO INTERNATIONAL, INC. · Class II
- AMSure® Enteral Feeding Irrigation Kit — AMSINO INTERNATIONAL, 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
- U Deliver Medical L.l.c.
Sources (1)
- FDA UDI c748f9dd-c1da-4ac2-a6c6-c4b105aea00e 34 fields · synced Jun 8, 2026