Hyperthermia Pump Accessory Kit

Basic Information

• Brand Name: Hyperthermia Pump Accessory Kit
• Primary DI: 00896128002183
• Version / Model: 902-00013
• Company Name: BELMONT INSTRUMENT CORPORATION
• Labeler DUNS: 078330362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-08
• Public Version: 4
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 2ec043a8-7b9f-412e-8afd-0c71c742debb

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40784	Extravascular-circulation hyperthermia system	An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. It is typically a computer-controlled configuration used for curative or palliative treatment by causing the temperature of the whole body, localized areas, or targeted organs to rise to temperatures greater than 43? Celsius. It is typically used in an oncology department.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896128002183	GS1

Premarket Submissions

Submission Number	Supplement Number
K152208	000