6" (15 cm) Microbore Extension Set with Clamp

GUDID 20634624090655

6" (15 cm) Microbore Intravascular Extension Set with Clamp

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set
Primary Device ID20634624090655
NIH Device Record Keyf925ff97-6905-4f93-a719-04cee5bf0467
Commercial Distribution StatusIn Commercial Distribution
Brand Name6" (15 cm) Microbore Extension Set with Clamp
Version Model Number9065
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624090651 [Primary]
GS120634624090655 [Package]
Contains: 00634624090651
Package: Shipper [200 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 Date2017-02-13

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