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) (10)

Premarket Exempt

No Yes

Clear

HIgH-Flo™ Needle Set - 00659443002944 Catalog Number : SUPER42606

Device Description : 26 Gauge Needle Sets 4 leg 6mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002951 Catalog Number : SUPER42609

Device Description : 26 Gauge Needle Sets 4 leg 9mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002968 Catalog Number : SUPER42612

Device Description : 26 Gauge Needle Sets 4 leg 12mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002975 Catalog Number : SUPER42614

Device Description : 26 Gauge Needle Sets 4 leg 14mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002982 Catalog Number : SUPER52604

Device Description : 26 Gauge Needle Sets 5 leg 4mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443002999 Catalog Number : SUPER52606

Device Description : 26 Gauge Needle Sets 5 leg 6mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443003002 Catalog Number : SUPER52609

Device Description : 26 Gauge Needle Sets 5 leg 9mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443003019 Catalog Number : SUPER52612

Device Description : 26 Gauge Needle Sets 5 leg 12mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443003026 Catalog Number : SUPER52614

Device Description : 26 Gauge Needle Sets 5 leg 14mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443003033 Catalog Number : SUPER62604

Device Description : 26 Gauge Needle Sets 6 leg 4mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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