Hang&Go

Basic Information

• Brand Name: Hang&Go
• Primary DI: M640R99001200001
• Version / Model: 000
• Catalog Number: R9900120
• Company Name: RAND SPA
• Labeler DUNS: 655010531
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 4
• Public Version Date: 2020-04-28
• Public Version Status: Update
• Public Device Record Key: 800ba898-b9cc-4a4c-be90-fb94cb588a3f
• Distribution End Date: 2020-02-11

Device Description

Kit for Hyperthermic Perfusion

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
47761	Intravascular/intracavitary-circulation hyperthermia system set	A collection of sterile devices used with an intravascular/intracavitary-circulation hyperthermia system for the circulation of blood/fluids, with or without added chemotherapeutic agents, between the patient and the system's extracorporeal circuit during cancer therapy. It typically consists of drains/catheters, tubing, connectors, manual clamps, and hard or soft reservoirs; some types may include in-line filters, an oxygenator, and temperature sensors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M640R99001200001	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius