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 ID: 10724995180383
• NIH Device Record Key: ca369515-a747-4da2-93bb-3ef1a03a8c75
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 710304
• Catalog Number: 710304
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995180386 [Primary]
GS1	00816765013113 [Previous]
GS1	10724995180383 [Package]; Contains: 00724995180386; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111648

FDA Product Code

• FCX: INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-10
• Device Publish Date: 2020-04-02

Devices Manufactured by US Endoscopy

• 00724995233327 - Duoswift: 2026-03-20 DuoSwift Combination Squeegee Brush - refill
• 10724995362635 - VIA: 2026-03-16 The VIA Procedure Kit - custom includes Enzymatic Sponge, Tray, Olympus 4-piece Valve Kit, BioShield Biopsy Valve, Absorbent Pad
• 10724995362642 - VIA: 2026-03-16 The VIA Procedure Kit - custom includes Enzymatic Sponge, Tray, Olympus 4-piece Valve Kit, BioShield Biopsy Valve, Absorbent Pad
• 10724995362659 - VIA: 2026-03-16 The VIA Procedure Kit - custom includes Enzymatic Sponge, Tray, Olympus 4-piece Valve Kit, BioShield Biopsy Valve, Transport Pad
• 10724995243750 - Exacto Mundo: 2025-08-27 The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
• 10724995243767 - Exacto Mundo: 2025-08-27 The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
• 10724995244535 - Lumiflex: 2025-08-27 LUMIFLEX BALLOON INFLATOR
• 00724995244545 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three