Oxy2Mask O2/EtCO2 OM-2125-14SLM

GUDID 00620974003175

Oxy2Mask O2/EtCO2 Adult

Southmedic Incorporated

Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set Breathing circuit gas-sampling/monitoring set

• Primary Device ID: 00620974003175
• NIH Device Record Key: 6bb94b34-174a-4c02-8114-9def1e40117d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxy2Mask O2/EtCO2
• Version Model Number: OM-2125-14SLM
• Catalog Number: OM-2125-14SLM
• 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
• 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	00620974003175 [Unit of Use]
GS1	10620974003172 [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 [Oxy2Mask O2/EtCO2]

• 00620974003229: Oxy2Mask O2/EtCO2 Plus Mask with Microsteam connector
• 00620974003212: Oxy2Mask O2/EtCO2 Plus
• 00620974003205: Oxy2Mask O2/EtCO2 Plus
• 00620974003182: Oxy2Mask O2/EtCO2 Adult Mask with Microsteam connector
• 00620974003175: Oxy2Mask O2/EtCO2 Adult
• 00620974003168: Oxy2Mask O2/EtCO2 Adult
• 00620974003151: Oxy2Mask O2/EtCO2 Adult
• 00620974003137: Oxy2Mask O2/EtCO2 Kid Mask with Microsteam connector
• 00620974003120: Oxy2Mask O2/EtCO2 Kid
• 00620974003687: Oxy2Mask O2/EtCO2 Plus