Q2 Checkmate Extension Set

GUDID 20634624095438

44 inch (122 cm) with 3 pressure activated checkvalves, inline checkvalve, detachable. Approximate priming volume 6.4mL.

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set
Primary Device ID20634624095438
NIH Device Record Keyecf5d6bf-571c-4ffd-ad13-bf669a5915c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQ2 Checkmate Extension Set
Version Model Number9543
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

Customer Support Contacts

Phone800-627-0226
Emailcustserv@questmedical.com
Phone800-627-0226
Emailcustserv@questmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624095434 [Primary]
GS120634624095438 [Package]
Contains: 00634624095434
Package: Shipper [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-10

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