Identity
- Trade Name
- Passio Pump Drainage System FDA UDI
- Generic Name
- Thoracic suction pump FDA UDI
- Device Name
- Starter Pac FDA UDI
- Model / Reference
- PAS-04 FDA UDI
- Description
- Starter Pac FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860099001322 FDA UDI
- FDA Product Code
- DWM FDA UDI
- GMDN Term
- Thoracic suction pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pleural/peritoneal drainage catheterization kitThoracic suction pump
Passio Pump Drainage System by Bearpac Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic suction pump.
- Thoraguard — Centese, Inc. · Class II
- Thopaz+ — Medela LLC · Class II
- ATMOS — ATMOS MedizinTechnik GmbH & Co. KG · Class II
- Thopaz+ — Medela LLC · Class II
- ATMOS — ATMOS MedizinTechnik GmbH & Co. KG · Class II
- Thopaz+ — Medela LLC · Class II
- Passio Handheld Control Unit — BEARPAC MEDICAL, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bearpac Medical, Llc
Sources (1)
- FDA UDI 39a0680a-6a67-46de-9947-ece63be8b8b5 34 fields · synced May 30, 2026