REPRO MED SYSTEMS, INC.

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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

CATHETERS, SUCTION, TRACHEOBRONCHIAL (BSY) (8) Pump, infusion (FRN) (2)

Premarket Exempt

No Yes

Clear

Res-Q-Vac - 00659443002647 Catalog Number : PLAKVAC1R

Device Description : PLACKVAC1 REPLACEMENT KIT NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002654 Catalog Number : PLAKVAC1

Device Description : PLACKVAC ASSEMBLY

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002661 Catalog Number : FSP6000

Device Description : DENTAL-E-VAC KIT W/FSP NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002678 Catalog Number : FSP6000R

Device Description : DENTAL-E-VAC REPL FSP NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002685 Catalog Number : FSP6001R

Device Description : DENTAL SOFT FSP REPL NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002692 Catalog Number : FSP6003

Device Description : DENTAL-E-VAC KIT W/PED NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002708 Catalog Number : P0000000B

Device Description : RES-Q-VAC®Pump - Bulk

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

RMS Precision Flow Rate TubingTM - 00659443002715 Catalog Number : L20KT

Device Description : Low Flow Rate Kit (3 x F30, 2 x F45, 8 x F60, 4 x F120, 3 x F180)

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

RMS Precision Flow Rate TubingTM - 00659443002722 Catalog Number : H20KT

Device Description : High Flow Rate Kit (2 x F275, 5 x F600, 5 x F900, 4 x F1200, 4 x F2400)

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Res-Q-Vac - 00659443002739 Catalog Number : PNCAN

Device Description : Ped Non-Sterile Canister Assembly

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

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