RenovaRP Paracentesis Kit GIS-32

GUDID 00893029002175

Large Volume Paracentesis Kit. The GI Supply RenovaRP Paracentesis Kit is intended to be used in conjunction with the GI Supply Renova RP Paracentesis Pump and GI Supply RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity. The GI Supply RenovaRP Paracentesis Kit is intended to be used medically trained healthcare professionals knowledgeable about paracentesis.

GI Supply, Inc.

Pleurocentesis/paracentesis kit

• Primary Device ID: 00893029002175
• NIH Device Record Key: 0382a97a-7369-431c-b7ba-01c6c6d12478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenovaRP Paracentesis Kit
• Version Model Number: GIS-32
• Catalog Number: GIS-32
• Company DUNS: 160990313
• Company Name: GI Supply, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893029002175 [Primary]
GS1	10893029002172 [Package]; Package: Kit [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970187

FDA Product Code

• LRO: General Surgery Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-14
• Device Publish Date: 2021-07-06

Devices Manufactured by GI Supply, Inc.

• 00893029002731 - RenovaRP: 2023-12-22 The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Ba
• 10893029002165 - RenovaRP Tube Set: 2022-08-18 RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remov
• 10893029002592 - MoonPants SM: 2021-07-28 MoonPants SM single-use non-sterile garment
• 10893029002608 - MoonPants ML: 2021-07-28 MoonPants ML single-use non-sterile garment
• 10893029002615 - MoonPants XL: 2021-07-28 MoonPants XL single-use non-sterile garment
• 10893029002622 - MoonPants Long: 2021-07-28 MoonPants Long single-use non-sterile garment
• 00893029002670 - SportShorts XS: 2021-07-28 SportShorts XS single-use non-sterile garment
• 00893029002687 - SportShorts SM: 2021-07-28 SportShorts SM single-use non-sterile garment