FDA.reportPublic FDA data

Jac-cell Medic

Primary DI
B460ATI0210
Brand
Jac-cell Medic
Company
9001-2030 Québec Inc
Model
ATI-021
Device description
Insulation Tester
Published
2017-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B460ATI0210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter device testerA battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1.2Inch
Height6Inch
Weight0.51Pound
Width3.5Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
253086045
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B460JA11591Jac-cell Medic Inc.JA-11592016-12-22
B460JA11601Jac-cell Medic Inc.JA-11602016-12-22
B460JA11681Jac-cell Medic Inc.JA-11682016-12-22
B460JA15201Jac-cell MedicJA-15202017-06-28
B460ATI014A0Jac-cell MedicATI-014A2017-04-03

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Primary DI, Brand, Company table
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