Identity
- Trade Name
- Denver FDA UDI
- Generic Name
- Pleural/peritoneal drainage catheterization kit FDA UDI
- Device Name
- DENVER™ ASCITES SHUNT PERCUTANEOUS ACCESS KIT SINGLE VALVE FDA UDI
- Model / Reference
- 42-2055 FDA UDI
- Description
- DENVER™ ASCITES SHUNT PERCUTANEOUS ACCESS KIT SINGLE VALVE FDA UDI
Identifiers
- Catalog Number
- 42-2055 FDA UDI
- Primary DI / UDI-DI
- 10885403076008 FDA UDI
- FDA Product Code
- KPM FDA UDI
- GMDN Term
- Pleural/peritoneal drainage catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5955 FDA UDI
- Commercial Distribution
- 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
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
Dimensions & Sizes
- Size
- Catheter Gauge — 11.5 French FDA UDI
Category: Pleural/peritoneal drainage catheterization kit
Denver by Carefusion 2200, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pleural/peritoneal drainage catheterization kit.
- PleurX — CAREFUSION 2200, INC. · Class II
- Aspira Drainage Supplies — Bard Access Systems, Inc. · Class II
- PeritX — Bard Peripheral Vascular · Class II
- ARROW — TELEFLEX INCORPORATED · Class I
- ReSolve® — Merit Medical Systems, Inc. · Class II
- Aspira® — Merit Medical Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class I
- Fuhrman — COOK INCORPORATED · Class I
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
- Carefusion 2200, Inc
Sources (1)
- FDA UDI 374257b1-cdf4-4379-a886-79959d4de95d 35 fields · synced Jun 8, 2026