Large Volume Paracentesis Kit GIS-28

GUDID 10893029002004

The GI Supply Large Volume Paracentesis Kit is intended to be used in conjunction with the GI Supply Paracentesis Pump to remove ascitic fluid from the abdominal cavity. The GI Supply Paracentesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis. The Sterile Kit contains standard components required for paracentesis procedure (1) 10cc and (1) 30cc luer locking syringe, (1) filter straw, (1) 3-pack povidone-iodine swabsticks, (1) fenestrated drape, (1) 18Ga and (1) 25Ga 1-½” Needles, (2) 5ml ampuls of 1% Lidocaine, (3) 5ml printed sample vials with caps, (1) #11 blade scalpel, (1) bandage, (5) 4x4” gauze pads and (3) alcohol prep pads; along with specially designed components required to work with the RP Pump (2) 1.6L Drainage bags, (1) Pump Tube set, (1) Paracentesis Device Assembly and (1) 15Ga Needle.

GI Supply, Inc.

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• Primary Device ID: 10893029002004
• NIH Device Record Key: e90af11a-1fc1-4e93-8a79-75ad64feaa5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Volume Paracentesis Kit
• Version Model Number: GIS-28
• Catalog Number: GIS-28
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893029002007 [Primary]
GS1	10893029002004 [Package]; Contains: 00893029002007; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970187

FDA Product Code

• LRO: General Surgery Tray (Kit)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-17
• Device Publish Date: 2016-09-24

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