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AMT Enfit® Transition Adapter

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
AMT Enfit® Transition Adapter FDA UDI
Generic Name
ENFit/non-ISO80369-standardized linear connector FDA UDI
Device Name
Male Enfit®-to-Stepped Male (Christmas Tree) Adapter (Pouched) FDA UDI
Model / Reference
ETRN102 FDA UDI
Description
Male Enfit®-to-Stepped Male (Christmas Tree) Adapter (Pouched) FDA UDI

Identifiers

Catalog Number
ETRN102, TRN102 FDA UDI
Primary DI / UDI-DI
00842071108007 FDA UDI
510(k) Number
K150034 FDA UDI
FDA Product Code
PIO FDA UDI
GMDN Term
ENFit/non-ISO80369-standardized 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/non-ISO80369-standardized linear connector

AMT 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/non-ISO80369-standardized 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 6e3f4c8b-975f-488d-985a-9de7d3fcf9fc 36 fields · synced Jun 9, 2026