OxyArm™ OA-HB-1125

GUDID 00620974000051

OxyArm Plus Clear Adjustable Head Band

Southmedic Incorporated

Vortex oxygen face mask

• Primary Device ID: 00620974000051
• NIH Device Record Key: 27718f80-0083-4e0c-9b13-18baa701ae81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyArm™
• Version Model Number: OA-HB-1125
• Catalog Number: OA-HB-1125
• 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	00620974000051 [Unit of Use]
GS1	10620974000058 [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

On-Brand Devices [OxyArm™]

• 10620974000034: OxyArm ETCO2 Disposable Diffuser Arm
• 00620974000099: OxyArm Plus Clear Adjustable Head Band with Nasal Cannula Arm and 7' tubing
• 00620974000075: OxyArm Plus Clear Adjustable Head Band with Diffuser Arm with 7' tubing
• 00620974000051: OxyArm Plus Clear Adjustable Head Band
• 00620974000044: OxyArm Disposable Cannula Arm
• 00620974000020: OxyArm Disposable Diffuser Arm