Piston Enteral Feeding Syringe with ENFit Connector

GUDID 00616784428413

Ring Top Syringe, 60 mL

DYNAREX CORPORATION

ENFit oral/enteral syringe, reusable
Primary Device ID00616784428413
NIH Device Record Key702d108f-0886-4db0-a752-2b68bc69441e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiston Enteral Feeding Syringe with ENFit Connector
Version Model Number4284
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784428413 [Primary]
GS100616784428437 [Package]
Package: Case [30 Units]
In Commercial Distribution

FDA Product Code

KYZSyringe, Irrigating (Non Dental)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

Devices Manufactured by DYNAREX CORPORATION

00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g 2026-02-04
00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet2026-02-03
00840117348790 - Flavored Oral Swab, For Professional And Hospital use 2026-01-29 Individually Wrapped
00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use2026-01-29 Individually Wrapped
00840117348837 - Oral Swabsticks, Flavored w/Dentrifice2026-01-29
00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use2026-01-29
00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13
00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.