Oxy2Mask™ OP-1425-8

GUDID 00620974003557

O2 Plus Mask with ear elastics

Southmedic Incorporated

Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask

• Primary Device ID: 00620974003557
• NIH Device Record Key: 5fc33e06-74d6-4598-90d5-9ccaae6c9ea3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxy2Mask™
• Version Model Number: OP-1425-8
• Catalog Number: OP-1425-8
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 25
• DM Exempt: true
• Pre-market Exempt: true
• 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(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	00620974003557 [Unit of Use]
GS1	10620974003554 [Primary]

FDA Product Code

• BYG: MASK, OXYGEN

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: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [Oxy2Mask™]

• 00620974003557: O2 Plus Mask with ear elastics
• 00620974003540: O2 Adult Mask with ear elastics
• 00620974003533: O2 Plus Mask with 14ft tubing
• 00620974003526: O2 Adult Mask with 14ft tubing
• 00620974003519: O2 Kid Mask with 14ft tubing