| Primary Device ID | 10700812016615 |
| NIH Device Record Key | 018a0f29-cf27-4791-a82e-baf26a2bc53b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medegen Medical Prodcuts |
| Version Model Number | 8705T |
| Catalog Number | 8705T |
| Company DUNS | 055527753 |
| Company Name | MEDEGEN MEDICAL PRODUCTS, LLC |
| Device Count | 10 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00700812016618 [Primary] |
| GS1 | 10700812016615 [Unit of Use] |
| HIBCC | H3628705T0 [Previous] |
| MMK | Container, Sharps |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-26 |
| Device Publish Date | 2020-05-18 |
| H3621872 - Medegen Medical products | 2023-08-18 Sharps: 23 Qt. Btl Red |
| 00673844000231 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 11X14 1.2Ml Red Pr Rl Pre Pak 1 |
| 00673844000248 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 23X23 1.1Mil Red Pr Rl Pre Pak |
| 00673844000255 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 33X40 1.2Ml Red Pr 250/Cs |
| 00673844000262 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 25X34 1.2Ml Red Pr 250/Cs |
| 00673844000279 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 25X34 1.2Ml Red Pr Pre Pak 200/ |
| 00673844000286 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 25X34 1.2Ml Red Pr Pre Pak 250/ |
| 00673844000293 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 38X45 1.5Ml Red Pr 200/Cs |