| Primary Device ID | 00810083350370 |
| NIH Device Record Key | ecb39251-f70a-4f32-b68c-4d1ec9b522bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WOLF-PACK / BIOSITE / BIOSITE PLUS |
| Version Model Number | BI8500 |
| Catalog Number | BI8500 |
| 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 | 00810083350363 [Package] Package: [1000 Units] In Commercial Distribution |
| GS1 | 00810083350370 [Package] Contains: 00810083350820 Package: [100 Units] In Commercial Distribution |
| GS1 | 00810083350820 [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 | 2024-01-12 |
| Device Publish Date | 2024-01-04 |
| 00810083350370 | BI8500 60 psi Transparent Needleless Neutral Valve |
| 00810083350257 | BI8000 Biosite Plus 60 psi Transparent Needleless Neutral Valve |
| 00810083350400 | BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension |
| 00810083350394 | BI8002 Clear Biosite Plus Neutral Pressure Needleless Valve w/8" Microbore Extension |
| 00810083350387 | BI8502 Opaque Biosite Plus Neutral Pressure Needless Valve w/8" Microbore Extension |
| 00810083350417 | BI8004 Clear Biosite Plus Neutral Pressure Needless Valve w/14" Microbore Extension |