| Primary Device ID | 00620974003151 |
| NIH Device Record Key | 60b06d74-6b79-4a30-9d82-e61899234083 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxy2Mask O2/EtCO2 |
| Version Model Number | OM-2125-8SLM |
| Catalog Number | OM-2125-8SLM |
| 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 |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00620974003151 [Unit of Use] |
| GS1 | 10620974003158 [Primary] |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-11 |
| Device Publish Date | 2023-12-01 |
| 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 |