| Primary Device ID | 30357515035432 |
| NIH Device Record Key | 84a73cc2-9423-47df-895c-349ff68b1e4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coborns/UltiGuard |
| Version Model Number | 09543CB |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00357515710031 [Unit of Use] |
| GS1 | 20357515035435 [Primary] |
| GS1 | 30357515035432 [Package] Contains: 20357515035435 Package: [12 Units] In Commercial Distribution |
| 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 | 2019-10-28 |
| Device Publish Date | 2019-10-18 |
| 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 |