Oxy2Pro PRM-2110-8M

GUDID 00620974003625

Oxy2Pro Procedural Adult Mask with Male Luer

Southmedic Incorporated

Breathing circuit gas-sampling/monitoring set

• Primary Device ID: 00620974003625
• NIH Device Record Key: 3bbb0f09-90f2-4884-be01-b93b2a3c5ed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxy2Pro
• Version Model Number: PRM-2110-8M
• Catalog Number: PRM-2110-8M
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974003625 [Unit of Use]
GS1	10620974003622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• 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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [Oxy2Pro]

• 00620974003632: Oxy2Pro Procedural Adult Mask with Microstream Connector
• 00620974003625: Oxy2Pro Procedural Adult Mask with Male Luer
• 00620974003618: Oxy2Pro Procedural Adult Mask with Female Luer
• 00620974003601: Oxy2Pro Procedural Plus Mask with Microstream Connector
• 00620974003106: Oxy2Pro Procedural Plus Mask with Male Luer
• 00620974003090: Oxy2Pro Procedural Plus Mask with Female Luer