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 - 00659443000407 Catalog Number : RMS42609

Device Description : 26 Gauge Needle Sets - 4 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 - 00659443000414 Catalog Number : RMS42612

Device Description : 26 Gauge Needle Sets - 4 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 - 00659443000421 Catalog Number : RMS42614

Device Description : 26 Gauge Needle Sets - 4 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 - 00659443000438 Catalog Number : RMS52604

Device Description : 26 Gauge Needle Sets - 5 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 - 00659443000445 Catalog Number : RMS52606

Device Description : 26 Gauge Needle Sets - 5 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 - 00659443000452 Catalog Number : RMS52609

Device Description : 26 Gauge Needle Sets - 5 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 - 00659443000469 Catalog Number : RMS52612

Device Description : 26 Gauge Needle Sets - 5 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 - 00659443000476 Catalog Number : RMS52614

Device Description : 26 Gauge Needle Sets - 5 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 - 00659443000483 Catalog Number : RMS62604

Device Description : 26 Gauge Needle Sets - 6 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 - 00659443000490 Catalog Number : RMS62606

Device Description : 26 Gauge Needle Sets - 6 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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