| Primary Device ID | 00357515710130 |
| NIH Device Record Key | 5a033dbb-2208-4bbe-9231-8ce9494ef2a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HealthMart/UltiCare |
| Version Model Number | 1543057 |
| Company DUNS | 024723541 |
| Company Name | ULTIMED, INC. |
| Device Count | 100 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00357515710130 [Unit of Use] |
| GS1 | 20357515430575 [Primary] |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
| 30357515745010 - Simpli | 2023-05-01 Simpli 4mm UltiGuard |
| 30357515745027 - Simpli | 2023-05-01 Simpli 5mm Pen Needle UltiGuard |
| 30357515745034 - Simpli | 2023-05-01 Simpli 6mm Pen Needle UltiGuard |
| 30357515745058 - Simpli | 2023-05-01 Simpli 8mm Pen Needle UltiGuard |
| 20357515460015 - UltiCare | 2023-03-09 1mL oral Syringe |
| 20357515460039 - UltiCare | 2023-03-09 3mL oral syringe |
| 10357515460056 - UltiCare | 2023-03-09 5mL oral syringe |
| 20357515460107 - UltiCare | 2023-03-09 10mL oral syringe |