Hang&Go PAC R9900117

GUDID M640R99001170001

Kit for hyperthermic perfusion

RAND SPA

Intravascular/intracavitary-circulation hyperthermia system set

• Primary Device ID: M640R99001170001
• NIH Device Record Key: 0b5173ef-ae3f-495c-9164-599047f61403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hang&Go PAC
• Version Model Number: 000
• 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
• 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	M640R99001170001 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-17
• Device Publish Date: 2017-02-21

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