7 in (18cm) Y-Extension Set w/ 2 check valves 9250

GUDID 20634624092505

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set
Primary Device ID20634624092505
NIH Device Record Key91d5d247-1474-47e6-a636-0274dcfb0ea1
Commercial Distribution StatusIn Commercial Distribution
Brand Name7 in (18cm) Y-Extension Set w/ 2 check valves
Version Model Number9250
Catalog Number9250
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
GS100634624092501 [Primary]
GS120634624092505 [Package]
Contains: 00634624092501
Package: Shipper [50 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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