Precision Delivery Trifurcated IV Extension Set

GUDID 20634624621125

QUEST MEDICAL INC

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Primary Device ID20634624621125
NIH Device Record Key237e38b2-1a0a-49b7-8423-7318e6328822
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Delivery Trifurcated IV Extension Set
Version Model NumberPDT05DF
Company DUNS041810693
Company NameQUEST MEDICAL 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624621121 [Primary]
GS120634624621125 [Package]
Contains: 00634624621121
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-02-15
Device Publish Date2021-02-05

On-Brand Devices [Precision Delivery Trifurcated IV Extension Set]

20634624621163PDTV05DF
20634624621156PDTV05F
20634624621149PDTV05
20634624621132PDT05F
20634624621125PDT05DF
20634624621118PDT05

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