Exoflex 53in. T-Extension Set

GUDID 00634624957794

QUEST MEDICAL INC

Intravenous administration tubing extension set
Primary Device ID00634624957794
NIH Device Record Key260a4bf2-79e2-4898-a18f-0c03aa2c80e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameExoflex 53in. T-Extension Set
Version Model Number95779
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
GS100634624957794 [Primary]
GS120634624957798 [Package]
Package: [50 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 Date2019-03-20
Device Publish Date2019-03-12

On-Brand Devices [Exoflex 53in. T-Extension Set ]

2063462495789795789
0063462495779495779

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