AccessGUDID - DEVICE: AMT Enfit® Transition Adapter (00842071107994)

GUDID

Device Identifier (DI) Information

Brand Name: AMT Enfit® Transition Adapter
Version or Model: ETRN101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ETRN101, TRN101
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071107994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: Male Enfit®-to-Male Luer Adapter (pouched)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64470	ENFit/Luer linear connector	A small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a Luer connection (either lock or slip) at the other end, intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with ENFit connection with another device that has Luer connection. It does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIO	Enteral Specific Transition Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150034	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e1c928f-a40d-4d7c-8e10-2a45fb1f161d
Public Version Date: July 14, 2023
Public Version Number: 4
DI Record Publish Date: August 31, 2016