IV Start Kit with Nitrile Gloves, Sterile-EO

GUDID 00616784470429

Dynarex Corporation

Basic intravenous administration set, noninvasive
Primary Device ID00616784470429
NIH Device Record Key36dd720e-0661-49b6-9d07-ac524f18b4dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameIV Start Kit with Nitrile Gloves, Sterile-EO
Version Model Number4704
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784470429 [Primary]
GS100616784470436 [Package]
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-08-27
Device Publish Date2022-01-06

Devices Manufactured by Dynarex Corporation

00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO 2025-08-27
00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO 2025-08-27
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