OxyMask™ II OP-7025-8
GUDID 00620974003281
O2 Plus Mask Non PVC
Southmedic Incorporated
Vortex oxygen face mask| Primary Device ID | 00620974003281 |
| NIH Device Record Key | f0d6bc45-b3fd-4981-b217-61e97a4b8af3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OxyMask™ II |
| Version Model Number | OP-7025-8 |
| Catalog Number | OP-7025-8 |
| Company DUNS | 246848147 |
| Company Name | Southmedic Incorporated |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00620974003281 [Unit of Use] |
| GS1 | 10620974003288 [Primary] |
FDA Product Code
| BYG | MASK, OXYGEN |
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 | 2022-06-14 |
| Device Publish Date | 2022-06-06 |
On-Brand Devices [OxyMask™ II]
| 00620974002758 | O2 Plus Mask |
| 00620974002741 | O2 Adult Mask |
| 00620974002734 | O2 Kid Mask |
| 00620974002727 | O2 Tyke Mask |
| 00620974003304 | O2 Tyke Mask Non PVC |
| 00620974003298 | O2 Kid Mask Non PVC |
| 00620974003281 | O2 Plus Mask Non PVC |
| 00620974003274 | O2 Adult Mask Non PVC |
| 00620974003267 | O2 Tyke Mask |
| 00620974003250 | O2 Kid Mask |
| 00620974003243 | O2 Plus Mask |
| 00620974003236 | O2 Adult Mask |
| 00620974003199 | O2/ETCO2 Plus Mask |
| 00620974003144 | O2/ETCO2 Adult Mask |
| 00620974003113 | O2/ETCO2 Kid Mask |
Trademark Results [OxyMask]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYMASK 76632339 3072633 Live/Registered |
Southmedic Incorporated 2005-02-28 |
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