BUDDY LITE, BATTERY HOUSING AND HEATER UNIT, UK

GUDID 30896128002498

BUDDY LITE, BATTERY HOUSING AND HEATER UNIT, UK, CHARGER

BELMONT INSTRUMENT CORPORATION

Conduction blood/fluid warmer
Primary Device ID30896128002498
NIH Device Record Keye014aa4d-bf5c-43dc-925c-77ad9c5c7fc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBUDDY LITE, BATTERY HOUSING AND HEATER UNIT, UK
Version Model Number905-00018
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
GS130896128002498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSBWarmer, Blood, Non-Electromagnetic Radiation

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

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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

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