| Primary Device ID | 00620974000204 |
| NIH Device Record Key | 86e5ee9e-f59d-4412-b32d-df70ba72f644 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OxyKid™ |
| Version Model Number | OK-7025-8 |
| Catalog Number | OK-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 |
| 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 | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00620974000204 [Unit of Use] |
| GS1 | 10620974000201 [Primary] |
| BYG | MASK, OXYGEN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-28 |
| Device Publish Date | 2020-12-18 |
| 10620974000225 | OxyKid Nebulizer Kit |
| 00620974000204 | OxyKid Non PVC with 7ft tubing |
| 00620974000167 | OxyKid Pediatric Mask with 14ft tubing |
| 00620974000150 | OxyKid Pediatric Mask with 7ft tubing |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OXYKID 78674046 3105286 Live/Registered |
Southmedic Incorporated 2005-07-20 |