RenovaRP

Basic Information

• Brand Name: RenovaRP
• Primary DI: 00893029002168
• Version / Model: GIS-30
• Catalog Number: GIS-30
• Company Name: GI Supply, Inc.
• Labeler DUNS: 160990313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-10
• Public Version: 4
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 0f2146df-41e9-4913-91aa-b69d47df1e70

Device Description

The RenovaRP® Tube Set is intended for use in conjunction with the RenovaRP Centesis Pump 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 Tube Set is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRO	General Surgery Tray	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33403	Pleurocentesis/paracentesis kit	A collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10893029002165	GS1	Box	5	In Commercial Distribution
Primary	00893029002168	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]