Avante

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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) (7) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (2)

Premarket Exempt

No Yes

Clear

Blood Pressure Cuff - 00815871022552 Catalog Number :

Device Description : THIGH SINGLE LUMEN 41-54CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022644 Catalog Number :

Device Description : INFANT CUFF DUAL LUMEN LATEX FREE, CUFF SIZE 7.8-13.5 CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022651 Catalog Number :

Device Description : INFANT CUFF SINGLE LUMEN LATEX FREE, CUFF SIZE 7.8-13.5 CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022668 Catalog Number :

Device Description : CHILD CUFF DUAL LUMEN LATEX FREE, CUFF SIZE 13-21 CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022675 Catalog Number :

Device Description : CUFF NEONATE

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022743 Catalog Number :

Device Description : NIBP Single Tube Bladder Cuff, Large Adult Long 33-47 CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022750 Catalog Number :

Device Description : NIBP Single Tube Bladder Cuff, Adult Extra Long 25-35 CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Waveline ECO - 00815871022767 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Waveline ECO with CO2 - 00815871022774 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

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