| Primary Device ID | 00860099001315 |
| NIH Device Record Key | 6d181d96-eb02-467c-8e88-28b79785c569 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Passio Handheld Control Unit |
| Version Model Number | PAS-03 |
| Company DUNS | 081178202 |
| Company Name | Bearpac Medical, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00860099001315 [Primary] |
| DWM | Apparatus, Suction, Patient Care |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-15 |
| Device Publish Date | 2025-07-07 |
| 00860099001315 - Passio Handheld Control Unit | 2025-07-15 |
| 00860099001315 - Passio Handheld Control Unit | 2025-07-15 |
| 00086000903220 - Passio Redressing Kit | 2024-03-08 |
| 10860099001398 - Passio Valve Cap Kit | 2024-03-08 |
| 00860099001308 - Passio Disposable Collection System | 2023-09-04 |
| 10860099001343 - Passio Catheter Valve Replacement Kit | 2023-09-04 |
| 00860099001322 - Passio Pump Drainage System | 2023-08-21 Starter Pac |
| 00860099001353 - Passio Adapter Kit | 2023-08-21 |