CO2EFFICIENT 710302

GUDID 10816765013097

The CO2EFFICIENT Endoscopic Insufflator 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: 10816765013097
• NIH Device Record Key: d6f0e570-4e8c-40fe-b66e-0c58a3d23025
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CO2EFFICIENT
• Version Model Number: 710302
• Catalog Number: 710302
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816765013097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053008

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: 5
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-17

On-Brand Devices [CO2EFFICIENT]

• 10816765013097: The CO2EFFICIENT Endoscopic Insufflator is designed to use CO2 as a distention media in the gast
• 00724995180379: The CO2EFFICIENT Endoscopic Insufflator is designed to use CO2 as a distention media in the gast