UNIVERSAL MEDICAL, INC.

UNIVERSAL MEDICAL, INC.

Address:1320 E Fortune Ave,Fresno,CA,93725,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (9) Cable, Electrode (IKD) (1)

Premarket Exempt

No Yes

Clear

Pacetrak Plus rev 3 - B14731160 Catalog Number :

Device Description : Transmitters and Receivers, Electrocardiograph, Telephone

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Cardiostation® Advantage Software - B147CA0 Catalog Number :

Device Description : Cardiostation Software sold with TTM module.

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Heartrak ECAT Patient Cable - B147CBECAT0 Catalog Number :

Device Description : Electrode cable

Device Class : 2

Duns Number: 803593073

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Cardiostation Premier Stand Alone Software - B147CSS0 Catalog Number :

Device Description : Cardiostation Software sold with wireless devices.

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Cardiostation Transtelephonic Module - B147CSTTM010 Catalog Number :

Device Description : Transmitters and Receivers, Electrocardiograph, Telephone

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

eCardiostation Software - B147EC0 Catalog Number :

Device Description : Software with CardioStation

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Fusion Air - B147FSAIR0 Catalog Number :

Device Description : Transmitters and Receivers, Electrocardiograph, Telephone

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Heartrak 2 - B147HT20 Catalog Number :

Device Description : Telephone electrocardiograph transmitter and receiver

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Heartrak ECAT - B147HTECAT010 Catalog Number :

Device Description : Transmitters and Receivers, Electrocardiograph, Telephone

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

Heartrak ECAT 2 - B147HTECAT020 Catalog Number :

Device Description : Transmitters and Receivers, Electrocardiograph, Telephone

Device Class : 2

Duns Number: 803593073

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

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