Portuguese, Hyperthermia Pump, 230V

GUDID 60896128002130

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system
Primary Device ID60896128002130
NIH Device Record Keyd7c9ecf8-f57c-4446-8b20-a856c54a0042
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortuguese, Hyperthermia Pump, 230V
Version Model Number902-00001A-P
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
GS160896128002130 [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

Devices Manufactured by BELMONT INSTRUMENT CORPORATION

07290107581301 - CritiCool Mini2024-04-24 CritiCool Mini Unit
20896128002095 - buddy™ Disposable Set2024-04-23 6 X Box 24=144
17290012127332 - CureWrap™ Pediatric, 79-91cm (8 pack)2024-03-27 Accessory for the CritiCool system.
00896128002077 - Hyperthermia Pump St In/Out Pt Line2024-02-19
00896128002169 - Hyperthermia Pump St In/Out Pt Line2024-02-19
00896128002176 - Hyperthermia Pump Accessory2024-02-19
00896128002190 - Hyperthermia Pump Accessory2024-02-19
00896128002237 - Hyperthermia Pump St In/Out Pt Line Kit w/ 3L Reservoir2024-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.