710304

GUDID 10724995180383

The CO2 insufflator tubing set is used in the gastrointestinal tract with the STERIS CO2 endoscopic insufflators.

US Endoscopy

Endoscopic insufflation tubing set, single-use
Primary Device ID10724995180383
NIH Device Record Keyca369515-a747-4da2-93bb-3ef1a03a8c75
Commercial Distribution StatusIn Commercial Distribution
Version Model Number710304
Catalog Number710304
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995180386 [Primary]
GS100816765013113 [Previous]
GS110724995180383 [Package]
Contains: 00724995180386
Package: Case [24 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

Devices Manufactured by US Endoscopy

10724995243750 - Exacto Mundo2025-08-27 The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
10724995243767 - Exacto Mundo2025-08-27 The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
10724995244535 - Lumiflex2025-08-27 LUMIFLEX BALLOON INFLATOR
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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.