ENFit Transition Adapter ETRN204, TRN204

GUDID 00842071133351

Rigid Med-Port Y-Port-to-Female ENFit Adapter (Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

ENFit/non-ISO80369-standardized linear connector
Primary Device ID00842071133351
NIH Device Record Key86cd5939-7563-47f8-b736-dc9b17859bbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameENFit Transition Adapter
Version Model NumberETRN204
Catalog NumberETRN204, TRN204
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071133290 [Primary]
GS100842071133351 [Package]
Contains: 00842071133290
Package: Box (TRN204) [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIOEnteral Specific Transition Connectors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-05
Device Publish Date2025-05-28

On-Brand Devices [ENFit Transition Adapter]

00842071133351Rigid Med-Port Y-Port-to-Female ENFit Adapter (Pouched), MDR
00842071133344Y-Port-to-Female ENFit Adapter (Pouched), MDR
00842071133337Female Catheter-to-Female ENFit Adapter (Pouched), MDR
00842071133320Female Luer/Oral-to-Female ENFit Adapter (Pouched), MDR
00842071133313Male ENFit-to-Stepped Male (Christmas Tree) Adapter (Pouched), MDR
00842071133306Male ENFit-to-Male Luer Adapter (Pouched), MDR

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