FDA.reportPublic FDA data

BIOBASE

Primary DI
06936895301318
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
BK-HW100
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06936895301318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936895301318069368953013186936895301318

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose thermostatA mains electricity (AC-powered) device designed to maintain a pre-set temperature range, meaning within a defined limited over and under temperature. This device will typically be used to regulate room temperatures, or it may be a device that regulates another medical device to keep it within a predetermined range.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22
06971674867272BIOBASER1:60mL×2 R2:20mL×22023-07-24
06971674867289BIOBASER1:18mL×4 R2:6mL×42023-07-24
06971674867296BIOBASER1:18mL×1 R2:6mL×12023-07-24
06971674867302BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867319BIOBASER1:90mL×1 R2:30mL×12023-07-24
06971674867326BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867777BIOBASECalibrator:1mL×12023-07-24

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
06973843220888Thermo Shaker Mixing Block Hangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220895ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
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
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
10815236020923HemoTemp II ActivatorLCR HALLCREST, LLC.JRG2022-06-16