OxyMulti-Mask™ OPHH-1425-8

GUDID 10620974000584

OxyMulti Kid Ultra W Ear Elastics, Adapter & 7ft Tubing

Southmedic Incorporated

Vortex oxygen face mask

• Primary Device ID: 10620974000584
• NIH Device Record Key: 4de75366-5d9c-4b24-86f1-85080dcd317c
• Commercial Distribution Discontinuation: 2022-06-06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyMulti-Mask™
• Version Model Number: OPHH-1425-8
• Catalog Number: OPHH-1425-8
• 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

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	00620974000587 [Unit of Use]
GS1	10620974000584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760489

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-05-26
• Device Publish Date: 2016-09-01

On-Brand Devices [OxyMulti-Mask™]

• 10620974000546: OXYMULTI MASK W EAR ELASTICS, ADAPTER & 7ft TUBING
• 10620974000584: OxyMulti Kid Ultra W Ear Elastics, Adapter & 7ft Tubing
• 00620974003595: OxyMulti-Mask™ Plus with Dual Standard Connector
• 00620974003588: OxyMulti-Mask™ Adult with Dual Standard Connector
• 00620974003571: OxyMulti-Mask™ Kid with Dual Standard Connector