25ft/7.6m IV Ext Set w/ Sleeve

GUDID 00634624957251

95725 25ft/7.6m IV Ext Set w/ Sleeve

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set
Primary Device ID00634624957251
NIH Device Record Key1b13abb7-29b0-43f6-8736-f0bac2de67fe
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ft/7.6m IV Ext Set w/ Sleeve
Version Model Number95725
Company DUNS041810693
Company NameQUEST MEDICAL INC
Device Count50
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
GS100634624957251 [Primary]
GS120634624957255 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPKTubing, Fluid Delivery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-06
Device Publish Date2017-07-25

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