Identity
- Trade Name
- KBMED FDA UDI
- Generic Name
- Enteral feeding bag/bottle FDA UDI
- Device Name
- Enteral Feeding Gravity Set, 1000cc, Large bore, case of 30pcs FDA UDI
- Model / Reference
- ENF02G-1000L FDA UDI
- Description
- Enteral Feeding Gravity Set, 1000cc, Large bore, case of 30pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850016172492 FDA UDI
- 510(k) Number
- K210854 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
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
Category: Enteral feeding bag/bottle
Kbmed by KB Medical (group), 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
- AVANOS — Avanos Medical, 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
Cleared under the same submission
K210854 also covers:
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
- KB Medical (group), Inc.
Sources (1)
- FDA UDI 227067f1-1748-432b-84de-9f7dca4df2a6 34 fields · synced May 30, 2026