| Primary Device ID | 00850025688871 |
| NIH Device Record Key | 09d01592-ce04-47a4-b753-1eb1618cc792 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BAXJECT II Hi-Flow |
| Version Model Number | 3400769 |
| Company DUNS | 041877817 |
| Company Name | Takeda Pharmaceuticals U.S.A., Inc. |
| Device Count | 1 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00642621074000 [Previous] |
| GS1 | 00850025688871 [Primary] |
| LHI | Set, I.V. Fluid Transfer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-20 |
| Device Publish Date | 2024-06-12 |
| 00850025688819 - myPKFiT for Healthcare Professionals | 2025-01-13 Web application used by Healthcare Professionals to generate dose calculations |
| 00850025688826 - myPKFiT for Patients Mobile Application | 2025-01-13 Mobile application used by patients for disease management |
| 00850025688871 - BAXJECT II Hi-Flow | 2024-06-20Needleless Transfer Device |
| 00850025688871 - BAXJECT II Hi-Flow | 2024-06-20 Needleless Transfer Device |
| 00850025688864 - BAXJECT II | 2024-03-08 Needleless Transfer Device |
| 00850025688888 - Anti-Drug Antibody Biomarker Specimen Collection Kit | 2023-11-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectings |