Hyperthermia Pump Accessory

GUDID 00896128002190

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system
Primary Device ID00896128002190
NIH Device Record Key5b7fe177-209c-45d4-a318-bdfbbaf6d0b4
Commercial Distribution Discontinuation2023-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHyperthermia Pump Accessory
Version Model Number902-00015
Company DUNS078330362
Company NameBELMONT INSTRUMENT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896128002190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-11-08

On-Brand Devices [Hyperthermia Pump Accessory]

00896128002190902-00015
00896128002176902-00011

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