REPRO MED SYSTEMS, INC.

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

Pump, infusion (FRN) (10) Immunoglobulin G (IgG) Infusion System (PKP) (2) Set, administration, intravascular (FPA) (2)

Premarket Exempt

No Yes

Clear

FREEDOM60® - 00659443000001 Catalog Number : F10050

Device Description : Mechanical Syringe Infusion Pump

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : PKP, FPA, FRN

Prescription Use : Yes

Device Count : 1

FreedomEdgeTM - 00659443000018 Catalog Number : F10020

Device Description : Mechanical Syringe Infusion Pump

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : PKP, FPA, FRN

Prescription Use : Yes

Device Count : 1

RMS Precision Flow Rate TubingTM - 00659443000025 Catalog Number : F0.5

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 - 00659443000032 Catalog Number : F1

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 - 00659443000049 Catalog Number : F2

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 - 00659443000056 Catalog Number : F3

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 - 00659443000063 Catalog Number : F3.8

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 - 00659443000070 Catalog Number : F5

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 - 00659443000087 Catalog Number : F8

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 - 00659443000094 Catalog Number : F10

Device Description : Flow Control Infusion Tubing

Device Class : 2

Duns Number: 048403299

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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