G11200101

GUDID 10724995208124

The Argon gas canister is used with gi4000 electrosurgical unit.

US Endoscopy

Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery argon gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder Electrosurgery gas/non-refillable cylinder

• Primary Device ID: 10724995208124
• NIH Device Record Key: 9473f2e1-ac1b-4dfe-aaaf-e4a413bac114
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Argon Gas-G1120010
• Catalog Number: G11200101
• 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: false
• 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
• 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
• 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

• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995208127 [Primary]
GS1	10724995208124 [Package]; Contains: 00724995208127; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172805

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

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: 2022-02-28
• Device Publish Date: 2022-02-18

Devices Manufactured by US Endoscopy

• 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
• 50724995216844 - Torrent: 2023-05-15 The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as st
• 50724995220681 - Assurance: 2023-03-30 The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purp
• 10724995220690 - Assurance: 2023-03-30 The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpo
• 10724995211537 - UroSeal: 2022-12-06 The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the workin