Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Enteral, Syringe, ISOSAF™, Single Use 100ml FDA UDI
- Model / Reference
- EISO-100 FDA UDI
- Description
- Enteral, Syringe, ISOSAF™, Single Use 100ml FDA UDI
Identifiers
- Catalog Number
- EISO-100 FDA UDI
- Primary DI / UDI-DI
- 05060590881132 FDA UDI
- FDA Product Code
- PNR FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Enteral by Gbuk Enteral Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Gbuk Enteral Limited
Sources (1)
- FDA UDI 1707adc9-29fa-41d5-adeb-9ea01ffb6602 35 fields · synced Jun 1, 2026