Identity
- Trade Name
- Enteral Feeding FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Enteral GraviFeed Syringe, 60 mL, TwistLok FDA UDI
- Model / Reference
- NGF-60 FDA UDI
- Description
- Enteral GraviFeed Syringe, 60 mL, TwistLok FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00020451100968 FDA UDI
- 510(k) Number
- K092986 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Enteral Feeding by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092986 also covers:
- Syringe, Piston — MPS MEDICAL, INC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
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
- Medela LLC
Sources (1)
- FDA UDI 65bf653a-edce-4b90-a097-4de16d2d858a 36 fields · synced May 31, 2026