Hang&Go R9900120

GUDID M640R99001200041

Kit for Hyperthermic Perfusion

RAND SPA

Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set

• Primary Device ID: M640R99001200041
• NIH Device Record Key: cab6c57b-4825-46f8-99e5-5290e695f74f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hang&Go
• Version Model Number: 004
• Catalog Number: R9900120
• Company DUNS: 655010531
• Company Name: RAND SPA
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M640R99001200041 [Primary]

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: 2021-02-22
• Device Publish Date: 2021-02-12

On-Brand Devices [Hang&Go]

• M640R99001200001: Kit for Hyperthermic Perfusion
• M640R99001200011: Kit for Hyperthermic Perfusion
• M640R99001200031: Kit for Hyperthermic Perfusion
• M640R99001200021: Kit for Hyperthermic Perfusion
• M640R99001200041: Kit for Hyperthermic Perfusion