| Primary Device ID | 20850789007950 |
| NIH Device Record Key | 7f3bd0a9-ce02-4d1c-aa21-e0d74b3e2e40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TrueCare Biomedix |
| Version Model Number | TCBEXTNFBM-7 |
| Catalog Number | TCBEXTNFBM-7 |
| Company DUNS | 005457284 |
| Company Name | Truecare Biomedix - USA |
| Device Count | 50 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com | |
| Phone | (866) 593-8444 |
| info@tcbiomedix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850789007956 [Unit of Use] |
| GS1 | 10850789007953 [Primary] |
| GS1 | 20850789007950 [Package] Contains: 10850789007953 Package: Case [500 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-13 |
| Device Publish Date | 2024-11-05 |