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 - 00659443000308 Catalog Number : RMS22609

Device Description : 26 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 - 00659443000315 Catalog Number : RMS22612

Device Description : 26 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

HIgH-Flo™ Needle Set - 00659443000322 Catalog Number : RMS22614

Device Description : 26 Gauge Needle Sets - 2 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 - 00659443000339 Catalog Number : RMS32604

Device Description : 26 Gauge Needle Sets - 3 needles - 4 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000346 Catalog Number : RMS32606

Device Description : 26 Gauge Needle Sets - 3 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 - 00659443000353 Catalog Number : RMS32609

Device Description : 26 Gauge Needle Sets - 3 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 - 00659443000360 Catalog Number : RMS32612

Device Description : 26 Gauge Needle Sets - 3 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 - 00659443000377 Catalog Number : RMS32614

Device Description : 26 Gauge Needle Sets - 3 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 - 00659443000384 Catalog Number : RMS42604

Device Description : 26 Gauge Needle Sets - 4 needles - 4 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000391 Catalog Number : RMS42606

Device Description : 26 Gauge Needle Sets - 4 needles - 6 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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