Identity
- Trade Name
- Curve FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- Curve Ascites Shunt PAK, 15.5 FR - Ascites Shunt Percutaneous Access Kit / Double-Valved FDA UDI
- Model / Reference
- 42-2020 FDA UDI
- Description
- Curve Ascites Shunt PAK, 15.5 FR - Ascites Shunt Percutaneous Access Kit / Double-Valved FDA UDI
Identifiers
- Catalog Number
- 42-2020 FDA UDI
- Primary DI / UDI-DI
- 10885403219894 FDA UDI
- FDA Product Code
- KPM FDA UDI
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5955 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Catheter Gauge — 15.5 French FDA UDI
Curve 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 815142de-da50-4ccd-b173-82e4963061cd 37 fields · synced Jun 8, 2026