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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) (9) Light, Surgical, Ceiling Mounted (FSY) (1)

Premarket Exempt

No Yes

Clear

VISION EX5 - 00815871022453 Catalog Number :

Device Description : DRE Vision EX5, FLOOR MODEL, BATTERY BACKUP

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022460 Catalog Number :

Device Description : ADULT SINGLE LUMEN 27-35CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022477 Catalog Number :

Device Description : ADULT DUAL LUMEN 27-35CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022484 Catalog Number :

Device Description : ADULT SINGLE LUMEN 27-35CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022491 Catalog Number :

Device Description : CHILD SINGLE LUMEN 13-21CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022507 Catalog Number :

Device Description : LARGE ADULT CUFF DUAL LUMEN/LATEX FREE CUFF SIZE 34-42 CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022514 Catalog Number :

Device Description : LARGE ADULT SINGLE LUMEN 34-42CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022521 Catalog Number :

Device Description : SMALL ADULT DUAL LUMEN 20-28CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022538 Catalog Number :

Device Description : SMALL ADULT SINGLE LUMEN 20-28CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Blood Pressure Cuff - 00815871022545 Catalog Number :

Device Description : THIGH DUAL LUMEN 41-54CM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

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