Capnoxygen® CO2-01-14

GUDID 10620974001475

Capnoxygen Mask (Adult)

Southmedic Incorporated

Breathing circuit gas-sampling/monitoring set

• Primary Device ID: 10620974001475
• NIH Device Record Key: 10f2dd11-048c-47c1-990b-2ad03d56bf45
• Commercial Distribution Discontinuation: 2022-06-06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capnoxygen®
• Version Model Number: CO2-01-14
• Catalog Number: CO2-01-14
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 25
• 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: true
• 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(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974001478 [Unit of Use]
GS1	10620974001475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971229

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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: 2022-05-26
• Device Publish Date: 2016-09-01

On-Brand Devices [Capnoxygen®]

• 10620974001871: Capnoxygen mask
• 10620974001529: Pediatric Capnoxygen Mask with 14ft oxygen tubing & Sampling Line Male 15ft
• 10620974001499: Pediatric Capnoxygen Mask with 14ft oxygen tubing
• 10620974001482: Ophthalmic Capnoxygen Mask (Adult) with 14ft oxygen tuding
• 10620974001475: Capnoxygen Mask (Adult)