Identity
- Trade Name
- RenovaRP FDA UDI
- Generic Name
- Pleurocentesis/paracentesis kit FDA UDI
- Device Name
- The Laborie RenovaRP® Centesis Kit is intended to be used in conjunction with the RenovaRP Pump, the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis. FDA UDI
- Model / Reference
- GIS-31 FDA UDI
- Description
- The Laborie RenovaRP® Centesis Kit is intended to be used in conjunction with the RenovaRP Pump, the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis. FDA UDI
Identifiers
- Catalog Number
- GIS-31 FDA UDI
- Primary DI / UDI-DI
- 00893029002236 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Pleurocentesis/paracentesis kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pleurocentesis/paracentesis kit
RenovaRP by GI Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- GI Supply, Inc.
Sources (1)
- FDA UDI 1cd0a70f-dd3f-4449-9c4a-9cb72b120446 36 fields · synced May 30, 2026