44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site 9541

GUDID 20634624095414

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set
Primary Device ID20634624095414
NIH Device Record Key851b7545-ddb5-437d-8290-615981f94694
Commercial Distribution StatusIn Commercial Distribution
Brand Name44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site
Version Model Number9541
Catalog Number9541
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
GS100634624095410 [Primary]
GS120634624095414 [Package]
Contains: 00634624095410
Package: Shipper [20 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-07-26

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