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 - 00659443000506 Catalog Number : RMS62609

Device Description : 26 Gauge Needle Sets - 6 needles - 9 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000513 Catalog Number : RMS62612

Device Description : 26 Gauge Needle Sets - 6 needles - 12 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000520 Catalog Number : RMS62614

Device Description : 26 Gauge Needle Sets - 6 needles - 14 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000537 Catalog Number : RMS12406

Device Description : 24 Gauge Needle Sets - 1 needle - 6 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000544 Catalog Number : RMS12409

Device Description : 24 Gauge Needle Sets - 1 needle - 9 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000551 Catalog Number : RMS12412

Device Description : 24 Gauge Needle Sets - 1 needle - 12 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000568 Catalog Number : RMS12414

Device Description : 24 Gauge Needle Sets - 1 needle - 14 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000575 Catalog Number : RMS22406

Device Description : 24 Gauge Needle Sets - 2 needles - 6 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000582 Catalog Number : RMS22409

Device Description : 24 Gauge Needle Sets - 2 needles - 9 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000599 Catalog Number : RMS22412

Device Description : 24 Gauge Needle Sets - 2 needles - 12 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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