OxyMask™ II OP-2125-8

GUDID 00620974003199

O2/ETCO2 Plus Mask

Southmedic Incorporated

Breathing circuit gas-sampling/monitoring set

• Primary Device ID: 00620974003199
• NIH Device Record Key: ee29185a-1aab-48ea-8bc8-0bb757981d2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyMask™ II
• Version Model Number: OP-2125-8
• Catalog Number: OP-2125-8
• 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
• 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
• 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00620974003199 [Unit of Use]
GS1	10620974003196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014211
• Premarket Notification: K222511

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [OxyMask™ II]

• 00620974002758: O2 Plus Mask
• 00620974002741: O2 Adult Mask
• 00620974002734: O2 Kid Mask
• 00620974002727: O2 Tyke Mask
• 00620974003304: O2 Tyke Mask Non PVC
• 00620974003298: O2 Kid Mask Non PVC
• 00620974003281: O2 Plus Mask Non PVC
• 00620974003274: O2 Adult Mask Non PVC
• 00620974003267: O2 Tyke Mask
• 00620974003250: O2 Kid Mask
• 00620974003243: O2 Plus Mask
• 00620974003236: O2 Adult Mask
• 00620974003199: O2/ETCO2 Plus Mask
• 00620974003144: O2/ETCO2 Adult Mask
• 00620974003113: O2/ETCO2 Kid Mask