AccessGUDID - DEVICE: Hyperthermia Pump Accessory (00896128002190)

GUDID

Device Identifier (DI) Information

Brand Name: Hyperthermia Pump Accessory
Version or Model: 902-00015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BELMONT INSTRUMENT CORPORATION

Primary DI Number: 00896128002190
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078330362 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152208	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b7fe177-209c-45d4-a318-bdfbbaf6d0b4
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: November 08, 2016