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

Blood Pressure Cuff (DXQ) (5) Doppler, Fetal, Ultrasound (LXE) (4) Monitor, Ultrasonic, Nonfetal (JAF) (1)

Premarket Exempt

Clear

VASOCUFF - 00852785008708 Catalog Number : CUFF-220D

Device Description : Vasocuff Vascular Digit Cuff, 2.5cm - LATEX FREE - DISPOSABLE

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

VASOCUFF - 00852785008715 Catalog Number : CUFF-240D

Device Description : Vasocuff Vascular Digit Cuff, 1.9cm - LATEX FREE - DISPOSABLE

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

VASOCUFF - 00852785008746 Catalog Number : CUFF-SET-210D

Device Description : Vasocuff Vascular Cuff Set, 12cm - LATEX FREE - DISPOSABLE - PACKAGE OF 10

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

VASOCUFF - 00852785008784 Catalog Number : CUFF-SET-242

Device Description : Vasocuff Vascular Cuff Mixed Set - 2x10cm, 4x12cm, 2x12cm long - PACKAGE OF 8

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

VASOCUFF - 00852785008791 Catalog Number : CUFF-SET-440

Device Description : Vasocuff Vascular Cuff Set, 4x10cm, 4x12cm - PACKAGE OF 8

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008807 Catalog Number : DD-901-D2

Device Description : DigiDop 901, Table Top Doppler, 2MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008814 Catalog Number : DD-901-D2W

Device Description : DigiDop 901, Table Top Doppler, 2MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008821 Catalog Number : DD-901-D3

Device Description : DigiDop 901, Table Top Doppler, 3MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008838 Catalog Number : DD-901-D3W

Device Description : DigiDop 901, Table Top Doppler, 3MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008845 Catalog Number : DD-901-D5

Device Description : DigiDop 901, Table Top Doppler, 5MHZ VASCULAR

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

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