| Primary Device ID | 20850789007721 |
| NIH Device Record Key | 54a298d5-22bd-47bd-83af-375761c8a55d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TrueCare Biomedix |
| Version Model Number | TCBEXT0.2 |
| Company DUNS | 005457284 |
| Company Name | U.S. Infusion, LLC |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850789007727 [Unit of Use] |
| GS1 | 10850789007724 [Primary] |
| GS1 | 20850789007721 [Package] Contains: 10850789007724 Package: Case [500 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
[20850789007721]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-08-04 |
| Device Publish Date | 2022-12-31 |
| 20850789007721 | TCBEXT0.2 |
| 20850789007714 | TCBEXT1.2 |
| 20850789007707 | TCBINF6481NC |