710304

GUDID 10816765013110

CO2 Endoscopic Insufflator Tubing Set

US Endoscopy

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 10816765013110
• NIH Device Record Key: bc1eecfb-ba39-4ff5-a315-dfc3dcb12e54
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765013113 [Primary]
GS1	10816765013110 [Package]; Contains: 00816765013113; Package: Box [24 Units]; Discontinued: 2020-03-31; Not 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-17

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• 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
• 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