Identity
- Trade Name
- ASEPT FDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- ASEPT PLEURAL DRAINAGE SYSTEM FDA UDI
- Model / Reference
- 622289 FDA UDI
- Description
- ASEPT PLEURAL DRAINAGE SYSTEM FDA UDI
Identifiers
- Catalog Number
- 622289 FDA UDI
- Primary DI / UDI-DI
- 04046964317514 FDA UDI
- FDA Product Code
- DWM FDA UDI
- GMDN Term
- Pleural catheter 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Pleural catheter
A comprehensive medical device that provides a reliable and effective solution for managing pleural effusions, pneumothoraces, and empyemas. The ASEPT Pleural Catheter System is designed to be inserted through an intercostal space and into the pleural cavity, allowing for the removal of fluid, air, blood, chyle, or pus.
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Also classified as Pleural catheter.
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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 |
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Manufacturer
- Manufacturer
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI 93429370-b252-4c95-a612-af168c5dcc69 36 fields · synced Jul 8, 2026