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) (7) Pump, infusion (FRN) (3)

Premarket Exempt

No Yes

Clear

RMS Precision Flow Rate TubingTM - 00659443000209 Catalog Number : F900

Device Description : Flow Control Infusion Tubing

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

RMS Precision Flow Rate TubingTM - 00659443000216 Catalog Number : F1200

Device Description : Flow Control Infusion Tubing

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

RMS Precision Flow Rate TubingTM - 00659443000223 Catalog Number : F2400

Device Description : Flow Control Infusion Tubing

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000230 Catalog Number : RMS12604

Device Description : 26 Gauge Needle Sets - 1 needle - 4 mm

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

HIgH-Flo™ Needle Set - 00659443000247 Catalog Number : RMS12609

Device Description : 26 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 - 00659443000254 Catalog Number : RMS12606

Device Description : 26 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 - 00659443000261 Catalog Number : RMS12612

Device Description : 26 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 - 00659443000278 Catalog Number : RMS12614

Device Description : 26 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 - 00659443000285 Catalog Number : RMS22604

Device Description : 26 Gauge Needle Sets - 2 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 - 00659443000292 Catalog Number : RMS22606

Device Description : 26 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

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