NCP-2025-8

GUDID 10620974001444

Pediatric CO2/O2 Nasal Cannula with 7ft O2 and CO2 tube

Southmedic Incorporated

Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 10620974001444
• NIH Device Record Key: 5b01927e-d4b4-4958-9531-79539f63c874
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NCP-2025-8
• Catalog Number: NCP-2025-8
• 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
• 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 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 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974001447 [Unit of Use]
GS1	10620974001444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131410

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-22
• Device Publish Date: 2016-09-01

Devices Manufactured by Southmedic Incorporated

• 00620974003687 - Oxy2Mask O2/EtCO2: 2024-02-05 Oxy2Mask O2/EtCO2 Plus
• 00620974003090 - Oxy2Pro: 2023-12-11 Oxy2Pro Procedural Plus Mask with Female Luer
• 00620974003106 - Oxy2Pro: 2023-12-11 Oxy2Pro Procedural Plus Mask with Male Luer
• 00620974003120 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Kid
• 00620974003137 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Kid Mask with Microsteam connector
• 00620974003151 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult
• 00620974003168 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult
• 00620974003175 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult