French, Hyperthermia Pump, 230V

GUDID 30896128002139

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system
Primary Device ID30896128002139
NIH Device Record Keyf567f883-f336-4dea-90e6-46fc2c05e5d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFrench, Hyperthermia Pump, 230V
Version Model Number902-00001A-F
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 Numbertrue
Manufacturing Datetrue
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
GS130896128002139 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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