| Primary Device ID | 00848838000546 |
| NIH Device Record Key | 8f774508-500a-40a0-b190-c84538849c62 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | R01186 |
| Company DUNS | 065769564 |
| Company Name | REMEL, INC. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8002556730 |
| ITechnicalSupport@remel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848838000546 [Primary] |
| GS1 | 00848838099441 [Unit of Use] |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00842558116419 - ACT I Transport PK/10 | 2024-08-14 |
| 00842558116426 - ACT II Transport PK/10 | 2024-08-14 |
| 00842558116433 - ACT II Dual Transport PK/10 | 2024-08-14 |
| 05032384519903 - ProSpecT | 2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST |
| 00848838002724 - REMEL | 2024-05-14 Pseudomonas P Agar 10/PK |
| 00848838009921 - REMEL | 2024-05-14 Thio Med w/o Ind, w/o Dex (5ml) 100/PK |
| 00848838009938 - REMEL | 2024-05-14 Thio Med w/o Ind, w/o Dex (5ml) 20/PK |
| 00848838001994 - REMEL | 2024-05-13 KBE (Kanamycin Bile Esculin) Agar 15/PK |