RenovaRP Kit No Catheter GIS-31

GUDID 10893029002233

The GI Supply RenovaRP Paracentesis Kit is intended to be used in conjunction with the GI Supply RenovaRP 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 by medically trained healthcare professionals knowledgeable about paracentesis.

GI Supply, Inc.

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• Primary Device ID: 10893029002233
• NIH Device Record Key: 1cd0a70f-dd3f-4449-9c4a-9cb72b120446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenovaRP Kit No Catheter
• Version Model Number: GIS-31
• Catalog Number: GIS-31
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893029002236 [Primary]
GS1	10893029002233 [Package]; Contains: 00893029002236; 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: 2021-07-16
• Device Publish Date: 2021-07-08

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