Identity
- Trade Name
- Biotronix Healthcare FDA UDI
- Generic Name
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
- Device Name
- Enteral Delivery Pump Bag Set w/ ENFit™* Connector FDA UDI
- Model / Reference
- GEED53006 FDA UDI
- Description
- Enteral Delivery Pump Bag Set w/ ENFit™* Connector FDA UDI
Identifiers
- Catalog Number
- GEED53006 FDA UDI
- Primary DI / UDI-DI
- 00850005165279 FDA UDI
- 510(k) Number
- K181276 FDA UDI
- FDA Product Code
- PIF FDA UDIKNT 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
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 kit, adult/paediatric, non-sterile
Biotronix Healthcare by Biotronix Healthcare Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enteral feeding kit, adult/paediatric, non-sterile.
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- 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
Cleared under the same submission
K181276 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
- Biotronix Healthcare Industries Inc.
Sources (1)
- FDA UDI c0233298-7299-44fe-89b7-9aff33a6aff9 37 fields · synced May 31, 2026