710602

GUDID 00816765013151

The Two tank shuttle valve system is for use with an insufflator to attach two medical grade CO2 cylinders simultaneously. This reduces the likelihood of running out of CO2 during a procedure.

US Endoscopy

High-pressure medical gas tubing
Primary Device ID00816765013151
NIH Device Record Keydd729a82-44cc-4b73-985e-7d7c5af0f597
Commercial Distribution Discontinuation2020-03-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number710602
Catalog Number710602
Company DUNS627879687
Company NameUS Endoscopy
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995180430 [Primary]
GS100816765013151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCXINSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-31
Device Publish Date2016-09-17

Devices Manufactured by US Endoscopy

00724995244545 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244552 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244569 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244576 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244583 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244590 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244606 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm no wire is made of nylon and is a progressive stage balloon capable of th
00724995244613 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progressive stage balloon capable of th

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.