Identity
- Trade Name
- PleurX FDA UDI
- Generic Name
- Pleural/peritoneal drainage catheterization kit FDA UDI
- Device Name
- PleurX Patient Starter Kit - 500 ML FDA UDI
- Model / Reference
- 50-0075 FDA UDI
- Description
- PleurX Patient Starter Kit - 500 ML FDA UDI
Identifiers
- Catalog Number
- 50-0075 FDA UDI
- Primary DI / UDI-DI
- 10885403273780 FDA UDI
- FDA Product Code
- DWM FDA UDI
- GMDN Term
- Pleural/peritoneal drainage catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 500 Milliliter FDA UDI
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 20bc4868-e947-4fb9-8bba-64b7e19ea347 38 fields · synced Sep 18, 2026