| Primary Device ID | 00620974000167 | 
| NIH Device Record Key | 1c5400e9-2396-430f-999c-bf7eafab6bb1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | OxyKid™ | 
| Version Model Number | OK-1125-14 | 
| Catalog Number | OK-1125-14 | 
| 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 | 00620974000167 [Unit of Use] | 
| GS1 | 10620974000164 [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 |