| Primary Device ID | 00810083350912 |
| NIH Device Record Key | fb61234e-87a9-414c-99f2-9b68dd1a7c65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOSITE/BIOSITE PLUS |
| Version Model Number | JR-011-AU |
| Catalog Number | JR-011-AU |
| Company DUNS | 117526048 |
| Company Name | Sensimedical LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810083350912 [Package] Contains: 00810083350929 Package: Master Case [200 Units] In Commercial Distribution |
| GS1 | 00810083350929 [Primary] |
| 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 | 2024-06-05 |
| Device Publish Date | 2024-05-28 |
| 00810083350974 | JR-020-LU Biosite Pediatric Bifurcated Extension Tube - Luer Lock |
| 00810083350967 | JR-024-AU Biosite Adult Bifurcated Extension Tube |
| 00810083350936 | JR-014-AU Biosite Adult Extension Tube |
| 00810083350912 | JR-011-AU Biosite Regular Set |
| 00810083350899 | JR-015-AU Biosite Surgical Set with Check Valve |
| 00810083350516 | JR-044-AU Biosite Transfer Spike |
| 00810083350455 | JR-017-AU Biosite Extension with Solution Filter |