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) (8) Oximeter (DQA) (2)

Premarket Exempt

No Yes

Clear

Aneroid Kits - 00786511074654 Catalog Number :

Device Description : BASIC BP-CGS W/ SPRAGUE STETH-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074692 Catalog Number :

Device Description : PREMIUM ANEROID BP-BUR-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074777 Catalog Number :

Device Description : PREMIUM ANEROID BP-RPK-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroids (82 etc.) - 00786511074784 Catalog Number :

Device Description : PREMIUM ANEROID BP-RPU-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroid Kits - 00786511075088 Catalog Number :

Device Description : BP-RPK & CLINCIAL LITE W/CASE-CB

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroid Kits - 00786511075095 Catalog Number :

Device Description : BP-RPU & CLINCIAL LITE W/CASE-CB

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Pulse Oximeter - 00786511075118 Catalog Number :

Device Description : BASIC PULSE OXIMETER-HPK-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Pulse Oximeter - 00786511075125 Catalog Number :

Device Description : BASIC PULSE OXIMETER-PUR-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Aneroid Kits - 00786511075217 Catalog Number :

Device Description : ANEROID BP-RPK W/CASE & SPRAGUE KIT-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Aneroid Kits - 00786511075224 Catalog Number :

Device Description : ANEROID BP-RPU W/CASE & SPRAGUE KIT-BX

Device Class : 2

Duns Number: 078803608

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

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