710304

GUDID 10816765013110

CO2 Endoscopic Insufflator Tubing Set

US Endoscopy

Endoscopic insufflation tubing set, single-use
Primary Device ID10816765013110
NIH Device Record Keybc1eecfb-ba39-4ff5-a315-dfc3dcb12e54
Commercial Distribution Discontinuation2020-03-31
Commercial Distribution StatusNot in 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
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
GS100816765013113 [Primary]
GS110816765013110 [Package]
Contains: 00816765013113
Package: Box [24 Units]
Discontinued: 2020-03-31
Not 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
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.