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Enteral Feeding

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name
Enteral Feeding FDA UDI
Generic Name
Nasogastric feeding tube FDA UDI
Device Name
Polyurethane Enteral Feeding Tube, 16", 8FR, Approx. Priming Vol. 0.80 mL, ENFit FDA UDI
Model / Reference
ENFPU1680 FDA UDI
Description
Polyurethane Enteral Feeding Tube, 16", 8FR, Approx. Priming Vol. 0.80 mL, ENFit FDA UDI

Identifiers

Primary DI / UDI-DI
00020451100418 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
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

This enteral feeding device provides a reliable and efficient means of accessing the stomach for patients requiring enteral nutrition, particularly those with compromised digestive systems. The Polyurethane Enteral Feeding Tube, ENFPU1680, is designed to be single-use, sterile, and implantable, while also being easy to clean and maintain. It features a unique design with circular markings that serve as insertion guides, making it suitable for patients in very ill or comatose situations.

Cleared under the same submission

K080328 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medela LLC

Sources (1)

  • FDA UDI 08844166-8764-4153-b8fb-de0706a1fc9e 36 fields · synced Jun 28, 2026