FDA.reportPublic FDA data

HemoTemp II Activator

Primary DI
M74490001
Brand
HemoTemp II Activator
Company
BIOSYNERGY, INC.
Model
9000
Published
2017-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JRGBlock, Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M74490001PackageHIBCC1Not in Commercial Distribution
M74490000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory heating blockA mains electricity (AC-powered) device which is primarily a heating element, with or without a thermostat, that is built into a compact block and is used as a stable dry heat source. It is typically used in the laboratory to heat, e.g., liquids, laboratory samples/objects.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070698154
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M74481000HemoCool Gel-Pak810081002018-01-10
M74490000HemoTemp II Activator90002017-06-01
M74420001HemoTemp20002016-09-01
M74450001StaFreez50002017-06-01
M74460001LabTemp 2060002017-06-01
M74420002HemoTemp20002016-09-01
M74450002StaFreez50002017-06-01
M74481001HemoCool Gel-Pak810081002018-01-10
M74461001LabTemp 4061002017-06-01
M74410004TempTrend10002016-09-01
M74411001TempTrend II11002016-09-01
M74410001TempTrend10002016-09-01
M74430001HemoTemp II30002017-02-08
M74460002LabTemp 2060002017-06-01
M74410002TempTrend10002016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973843220871Thermo Cell Mixing Block Hangzhou Bioer Technology Co., Ltd.JRG2025-02-11
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06973843220901ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220918ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220925ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220932ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220949ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220956ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220963ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220970ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220987ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220994ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221007ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221014ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221021ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221038ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221052ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221069ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221076ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221083ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221120Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221137Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221144ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06936895301318BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301325BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301332BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301349BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
09349458005443ThermoBrite Elite InstrumentLEICA BIOSYSTEMS MELBOURNE PTY LTDJRG2022-07-18
00815236020926HemoTemp II ActivatorLCR HALLCREST, LLC.JRG2022-06-16