Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- ENFit-formatted protective cap FDA UDI
- Device Name
- Enteral, Syringe Accessories, Push Fit Cap, Single Use FDA UDI
- Model / Reference
- PFCO-50NS FDA UDI
- Description
- Enteral, Syringe Accessories, Push Fit Cap, Single Use FDA UDI
Identifiers
- Catalog Number
- PFCO-50NS FDA UDI
- Primary DI / UDI-DI
- 05060590883648 FDA UDI
- FDA Product Code
- KYX FDA UDI
- GMDN Term
- ENFit-formatted protective cap FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6430 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: ENFit-formatted protective cap
Enteral by Gbuk Enteral Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit-formatted protective cap.
- RxCrush — Resolve Designs LLC · Class I
- Enteral Feeding — Medela LLC · Class II
- Tamper Evident Cap with ENFit — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class II
- Tamper Evident Cap for use with ENFit — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class II
- Enteral — GBUK ENTERAL LIMITED · Class I
- Enteral — GBUK ENTERAL LIMITED · Class II
- Enteral — GBUK ENTERAL LIMITED · Class II
- Enteral — GBUK ENTERAL LIMITED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Gbuk Enteral Limited
Sources (1)
- FDA UDI 65bfe363-a86e-4bfe-9341-2cd361350077 34 fields · synced May 29, 2026