CO2MPACT 710300

GUDID 10816765013103

The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

US Endoscopy

Gastrointestinal endoscopic insufflator

• Primary Device ID: 10816765013103
• NIH Device Record Key: 51cc574e-517b-4d08-8fbe-ad1955e40a03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2MPACT
• Version Model Number: 710300
• Catalog Number: 710300
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995180362 [Primary]
GS1	10816765013103 [Primary]

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

• 00724995226732 - Padlock Clip: 2024-11-08 The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and (TouchSoft Coagulator Probe.
• 10724995197688 - DEFENDO: 2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction valve - 2-piece kit is used to control the air/water function of an endosco
• 10724995217409 - DEFENDO: 2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve 3-piece kit
• 10724995183278 - VIA: 2024-06-11 The VIA Procedure Kit-custom includes transport pad, gauze, Via Basin, enzymatic sponge, lubricating jelly, suction tubing, gown
• 00724995227340 - NA: 2023-11-21 gi400 Electrosurgery Unit Evaluation Kit
• 00724995199296 - truFreeze: 2023-07-19 truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during both active and passive venting p
• 20724995221618 - Ascendo: 2023-07-19 Ascendo Submucosal Lifting Agent
• 10724995216839 - Torrent: 2023-05-15 The Torrent irrigation scope connector is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile w