OxyMask™ OM-1125-14

GUDID 00620974000259

OxyMask with 14ft tubing

Southmedic Incorporated

Vortex oxygen face mask

• Primary Device ID: 00620974000259
• NIH Device Record Key: 118cbcd0-4278-4251-a27e-6ff214169d99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyMask™
• Version Model Number: OM-1125-14
• Catalog Number: OM-1125-14
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 25
• DM Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974000259 [Unit of Use]
GS1	10620974000256 [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: 2020-12-28
• Device Publish Date: 2020-12-18

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• 10620974000300: OxyMask ETCO2 with ear elastics and 14ft tubing
• 10620974000294: OxyMask ETCO2 with ear elastics and 7ft tubing
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• 00620974000334: OxyMask Non PVC with 7ft tubing
• 00620974000266: OxyMask with ear elastics and 7ft tubing
• 00620974000259: OxyMask with 14ft tubing
• 00620974000242: OxyMask with 7ft tubing