Hang&Go PAC R9900117

GUDID M640R99001170031

Kit for hyperthermic perfusion

RAND SPA

Intravascular/intracavitary-circulation hyperthermia system set

• Primary Device ID: M640R99001170031
• NIH Device Record Key: c5657c50-6793-4430-aa96-87b672bc75fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hang&Go PAC
• Version Model Number: 003
• Catalog Number: R9900117
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M640R99001170031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161613

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Hang&Go PAC]

• M640R99001170001: Kit for hyperthermic perfusion
• M640R99001170011: Kit for hyperthermic perfusion
• M640R99001170021: Kit for hyperthermic perfusion
• M640R99001170031: Kit for hyperthermic perfusion