16 in Exoflex IV Ext Set

GUDID 20634624957910

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set
Primary Device ID20634624957910
NIH Device Record Keyd64a13c0-17f2-49e2-a2c0-b128b329fa8b
Commercial Distribution StatusIn Commercial Distribution
Brand Name16 in Exoflex IV Ext Set
Version Model Number95791
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
GS100634624957916 [Primary]
GS120634624957910 [Package]
Contains: 00634624957916
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 Date2021-03-22
Device Publish Date2021-03-12

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20634624101306 - Q2 IV Administration Set2022-12-14
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20634624921096 - High-Flow 4-Way Stopcock2022-12-14
20634624921102 - High-Flow 4-Way Stopcock2022-12-14

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