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ENFit Transition Adapter

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
ENFit Transition Adapter FDA UDI
Generic Name
ENFit/Luer linear connector FDA UDI
Device Name
Male ENFit-to-Male Luer Adapter (Pouched), MDR FDA UDI
Model / Reference
ETRN101 FDA UDI
Description
Male ENFit-to-Male Luer Adapter (Pouched), MDR FDA UDI

Identifiers

Catalog Number
ETRN101, TRN101 FDA UDI
Primary DI / UDI-DI
00842071133245 FDA UDI
510(k) Number
K150034 FDA UDI
FDA Product Code
PIO FDA UDI
GMDN Term
ENFit/Luer linear connector 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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: ENFit/Luer linear connector

ENFit Transition Adapter by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENFit/Luer linear connector.

Cleared under the same submission

K150034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (1)

  • FDA UDI 172eecc1-e9bd-4bfb-8930-9df4bff7dbc3 36 fields · synced Jun 9, 2026