RASHMAN CORPORATION

RASHMAN CORPORATION

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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) (9) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

Aneroids (82 etc.) - 00786511000677 Catalog Number :

Device Description : NON-LATEX BULB/BLADDER -SLD PK

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511000707 Catalog Number :

Device Description : BASIC ANEROID BP-BLK-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511000806 Catalog Number :

Device Description : BP W/ COTTON CUFF-BP-BLK-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511000813 Catalog Number :

Device Description : TRADITIONAL HOME BP SET-BLK-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Pulse Oximeter - 00786511072612 Catalog Number :

Device Description : BASIC PULSE OXIMETER-BLK-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074067 Catalog Number :

Device Description : PREMIUM ANERIOD BP-RPU-CL

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074074 Catalog Number :

Device Description : PREMIUM ANERIOD BP-RPK-CL

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074173 Catalog Number :

Device Description : NYLON CUFF W/2-TUBE BLADDER-RPK-BULK

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074180 Catalog Number :

Device Description : NYLON CUFF W/2-TUBE BLADDER-RPU-BULK

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074197 Catalog Number :

Device Description : NYLON CUFF W/2-TUBE BLADDER-OBK-BULK

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

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