| Primary Device ID | 00848838014369 | 
| NIH Device Record Key | f13ec28e-ff04-41dd-9c61-5475d7e4985e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | R10325 | 
| Company DUNS | 065769564 | 
| Company Name | REMEL, INC. | 
| Device Count | 10 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | |
| Phone | 8002556730 | 
| ITechnicalSupport@remel.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00848838014369 [Primary] | 
| GS1 | 00848838099656 [Unit of Use] | 
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-24 |