NEWMAN MEDICAL LLC

Address:5350 VIVIAN STREET,Arvada,CO,80002,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

Monitor, Ultrasonic, Nonfetal (JAF) (6) Doppler, Fetal, Ultrasound (LXE) (4)

Premarket Exempt

Clear

DigiDop - 00852785008500 Catalog Number : DD-700-VASC

Device Description : DigiDop 700 VASC combo with 5MHz and 8MHz vascular probes

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008517 Catalog Number : DD-300-VASC

Device Description : DigiDop 300 VASC combo with 5MHz and 8MHz vascular probes

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008524 Catalog Number : DD-PAD

Device Description : DigiDop 300, non-display, 8MHZ VASCULAR PROBE, 1x10cm cuff, 1x12cm cuff, aneroid DigiDop 300, non-display, 8MHZ VASCULAR PROBE, 1x10cm cuff, 1x12cm cuff, aneroid, carry bag, user manual, quick reference guides.

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008531 Catalog Number : D2

Device Description : 2MHz obstetrical probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008548 Catalog Number : D2W

Device Description : 2MHz waterproof obstetrical probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008555 Catalog Number : D3

Device Description : 3MHz obstetrical probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008562 Catalog Number : D3W

Device Description : 3MHz waterproof obstetrical probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008579 Catalog Number : D5

Device Description : 5MHz vascular probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008586 Catalog Number : D8

Device Description : 8MHz vascular probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008593 Catalog Number : DPPG

Device Description : Audio PPG vascular probe (probe only)

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

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