RenovaRP Fluid Drainage Bag GIS-29

GUDID 00893029002151

RenovaRP Fluid Drainage Bag to be used with RenovaRP Paracentesis Pump - sold in box of 20

GI Supply, Inc.

Pleurocentesis/paracentesis kit

• Primary Device ID: 00893029002151
• NIH Device Record Key: 5df67407-7675-4c3c-8a7c-3060a5f240af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenovaRP Fluid Drainage Bag
• Version Model Number: GIS-29
• Catalog Number: GIS-29
• 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: false
• 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: false
• Labeled No Natural Rubber Latex: true
• 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
• Phone: 800-451-5797
• Email: info@gi-supply.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893029002151 [Primary]
GS1	10893029002158 [Package]; Package: Box of 20 [20 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: 2021-07-15
• Device Publish Date: 2021-07-07

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