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

Set, administration, intravascular (FPA) (6) CATHETERS, SUCTION, TRACHEOBRONCHIAL (BSY) (4)

Premarket Exempt

No Yes

Clear

Res-Q-Vac - 00659443002746 Catalog Number : R1F1E108N

Device Description : REPL FSP RIGID ET 8FR 3.5/14 NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002753 Catalog Number : R1N1B10LS

Device Description : REPL NSC RGD/SFT 10FR 35/14 14FR 14

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002760 Catalog Number : P0000000BM

Device Description : RES-Q-VAC BULK PACK MILITARY

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

Res-Q-Vac - 00659443002777 Catalog Number : P1N1S108N

Device Description : Pump NSC Soft 8FR 35/14 NS

Device Class : 1

Duns Number: 048403299

Premarket Exempt : No

Product Code : BSY

Prescription Use : No

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002784 Catalog Number : SUPER12604

Device Description : 26 Gauge Needle Sets 1 leg 4mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002791 Catalog Number : SUPER12606

Device Description : 26 Gauge Needle Sets 1 leg 6mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002807 Catalog Number : SUPER12609

Device Description : 26 Gauge Needle Sets 1 leg 9mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002814 Catalog Number : SUPER12612

Device Description : 26 Gauge Needle Sets 1 leg 12 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002821 Catalog Number : Super12614

Device Description : 26 Gauge Needle Sets 1 leg 14 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002838 Catalog Number : SUPER22604

Device Description : 26 Gauge Needle Sets 2 leg 4mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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