Ameritus ENFit

FDA UDI

Class II (US FDA UDI)

by Kentec Medical, Inc.

Identity

Trade Name: Ameritus ENFit FDA UDI
Generic Name: Nasogastric/orogastric tube FDA UDI
Device Name: 8fr 50cm single port feeding tube with ENFit connector FDA UDI
Model / Reference: ENF-80P-50 FDA UDI
Description: 8fr 50cm single port feeding tube with ENFit connector FDA UDI

Identifiers

Catalog Number: ENF-80P-50 FDA UDI
Primary DI / UDI-DI: 10817522012322 FDA UDI
510(k) Number: K100526 FDA UDI
FDA Product Code: FPD FDA UDI
GMDN Term: Nasogastric/orogastric 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Nasogastric/orogastric tube

Ameritus ENFit by Kentec Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasogastric/orogastric tube.

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VYGON — Vygon Corp. · Class II
Aquarius — DEGANIA SILICONE LTD · Class II
AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. — ANDERSEN PRODUCTS, INC. · Class II
Maglinte — COOK INCORPORATED · Class II
Vesco Medical Pediatric Nasogastric Feeding Tubes — CAIR LGL · Class II
AN11.05 - 16 Fr. Nasogastric Tube (5-lang) (Box 10 Ct.) — ANDERSEN PRODUCTS, INC. · Class II

Cleared under the same submission

K100526 also covers:

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: Kentec Medical, Inc.

Sources (1)

FDA UDI 9587079c-b5ee-4b53-885d-31cd708564af 36 fields · synced May 30, 2026