REM

GUDID 00813153026502

Bifurcated Minibore Extension Set

CODAN US CORPORATION

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Primary Device ID00813153026502
NIH Device Record Keyc583bab5-38f9-4312-a2ba-e0d145455348
Commercial Distribution StatusIn Commercial Distribution
Brand NameREM
Version Model NumberBC 2148
Company DUNS058027475
Company NameCODAN US CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813153026502 [Package]
Contains: 10813153026509
Package: [1 Units]
In Commercial Distribution
GS110813153026509 [Primary]

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-10
Device Publish Date2021-12-31

Devices Manufactured by CODAN US CORPORATION

00813153026373 - Codan2022-02-08 Minibore Extension Set with Filter
00813153026502 - REM2022-01-10Bifurcated Minibore Extension Set
00813153026502 - REM2022-01-10 Bifurcated Minibore Extension Set
00813153026847 - Codan2021-12-08 Reinforced J-Loop Extension Set with a Spinlock & a SWAN-LOCK, Needle-Free Connector
00813153021767 - Codan2021-11-25 Three Gang 4-way Swabable Stopcocks on a Plate
00813153026984 - Codan2021-11-08 Administration Set with 60 drop Vented Chamber, Needlefree Y-site, Stopcocks & Extension Set
00813153026892 - Codan2021-10-08 Transfer Set
00813153026908 - Codan2021-10-08 Transfer Set
10813153026929 - Codan2021-10-08 Trifurcated Extension Set

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