CLR Port Injector

GUDID 00850052377021

CLR Medical

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Primary Device ID00850052377021
NIH Device Record Key6c1bfd62-89f9-4654-8c88-7902814ffc02
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLR Port Injector
Version Model NumberS012-01-016
Company DUNS080279373
Company NameCLR Medical
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850052377007 [Primary]
GS100850052377021 [Package]
Contains: 00850052377007
Package: [20 Units]
In Commercial Distribution

FDA Product Code

GCEAdaptor, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-06
Device Publish Date2024-05-29

Devices Manufactured by CLR Medical

00850052377021 - CLR Port Injector2024-06-06
00850052377021 - CLR Port Injector2024-06-06
00860003054901 - CLR Irrigator2024-06-06
00860003054956 - CLR Port2024-06-06
00850052377014 - CLR Port Cap2024-06-06
00860003054949 - CLR Medical2021-11-15

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