Identity
- Trade Name
- Enteral Feeding FDA UDI
- Generic Name
- Nasogastric feeding tube FDA UDI
- Device Name
- Polyurethane Enteral Feeding Tube, 36", 5FR, Approx. Priming Vol. 0.65 mL, ENFit, Low Dose FDA UDI
- Model / Reference
- ENFPU3650LD FDA UDI
- Description
- Polyurethane Enteral Feeding Tube, 36", 5FR, Approx. Priming Vol. 0.65 mL, ENFit, Low Dose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00020451101552 FDA UDI
- 510(k) Number
- K080328 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Nasogastric feeding tube 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
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
Category: Nasogastric feeding tube
Enteral Feeding by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasogastric feeding tube.
- MED-RX — Canadian Hospital Specialties Limited · Class II
- ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector — ENVIZION MEDICAL LTD · Class II
- NeoDevices, Inc. — NEODEVICES INC · Class II
- CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
- VYGON — Vygon Corp. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
- Enteral — GBUK ENTERAL LIMITED · Class II
Cleared under the same submission
K080328 also covers:
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medela LLC
Sources (1)
- FDA UDI 56c200c8-1691-4349-a2b7-e40a1ccb64fb 35 fields · synced May 31, 2026