FDA.reportPublic FDA data

TekCare Blood Pressure Monitor

Primary DI
04710953421345
Brand
TekCare Blood Pressure Monitor
Company
AVITA CORPORATION
Model
BPM19
Device description
BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.
Published
2018-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710953421345PackageGS140In Commercial Distribution
04710953421338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710953421345047109534213454710953421345
04710953421338047109534213384710953421338

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023275
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
04710953421628Harbor Freight Tools584602020-10-13
04710953421635Harbor Freight Tools584602020-10-13
04710953421598TekCare Non-Contact Infrared ThermometerNT192020-05-15
04710953421604TekCare Non-Contact Infrared ThermometerNT192020-05-15
04710953421512TekCare Touch Free Infrared ThermometerNT172020-04-15
04710953421529TekCare Touch Free Infrared ThermometerNT172020-04-15
04710953421468TekCare Green-Type Infrared ThermometerNT1G2019-11-29
04710953421338TekCare Blood Pressure MonitorBPM192018-12-31
04710953420942Blood pressure monitor622202017-04-24
04710953421161Blood pressure monitorBPA-O3002018-08-12
04710953421291TekCare Touch Free Infrared ThermometerNT112018-12-31
04710953421314TekCare Infrared ThermometerTS462018-12-31
04710953421307TekCare Touch Free Infrared ThermometerNT112018-12-31
04710953421321TekCare Infrared ThermometerTS462018-12-31

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Primary DI, Brand, Company table
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