Identity
- Trade Name
- PleurX FDA UDI
- Generic Name
- Pleural catheter syringe-infusion set FDA UDI
- Device Name
- PleurX Catheter Access Kit FDA UDI
- Model / Reference
- 50-7280 FDA UDI
- Description
- PleurX Catheter Access Kit FDA UDI
Identifiers
- Catalog Number
- 50-7280 FDA UDI
- Primary DI / UDI-DI
- 10885403185694 FDA UDI
- FDA Product Code
- DWM FDA UDIPNG FDA UDI
- GMDN Term
- Pleural catheter syringe-infusion set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5050 FDA UDI876.5630 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
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
No
FDA UDI
Category: Pleural catheter syringe-infusion set
PleurX by Carefusion 2200, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Carefusion 2200, Inc.
Sources (1)
- FDA UDI fb28bd55-3a4c-4040-89c6-a66ac044dc83 35 fields · synced Sep 18, 2026