Italian, Hyperthermia Pump, 230V

GUDID 50896128002133

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system
Primary Device ID50896128002133
NIH Device Record Key96f9231f-6e91-4486-8edd-2321bd12ffe6
Commercial Distribution StatusIn Commercial Distribution
Brand NameItalian, Hyperthermia Pump, 230V
Version Model Number902-00001A-I
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
GS150896128002133 [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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