| Primary Device ID | 00384849904300 |
| NIH Device Record Key | d6f48868-0cdf-422e-821e-64e982d5f965 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy Insulin Syringes |
| Version Model Number | 990430 |
| Catalog Number | 990430 |
| Company DUNS | 832875905 |
| Company Name | PRODIGY DIABETES CARE, LLC |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384840904323 [Unit of Use] |
| GS1 | 00384843904306 [Package] Package: Corrugated Carton [5 Units] In Commercial Distribution |
| GS1 | 00384849904300 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-12 |
| Device Publish Date | 2016-09-22 |
| 00384849904393 | Prodigy Insulin Syringes 31G 8mm 3/10cc |
| 00384843904382 | Prodigy Insulin Syringes 31G 8mm 3/10cc |
| 00384849904379 | Prodigy Insulin Syringes 31G 8mm 1/2cc |
| 00384843904351 | Prodigy Insulin Syringes 31G 8mm 1/2cc |
| 00384849904324 | Prodigy Insulin Syringes 28G 12.7mm 1cc |
| 00384849904300 | Prodigy Insulin Syringes 28G 12.7mm 1cc |