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Koru

FDA UDI

Class II (US FDA UDI)

by Repro Med Systems, Inc.

Identity

Trade Name
KORU FDA UDI
Generic Name
Ambulatory non-insulin infusion pump, mechanical, reusable FDA UDI
Device Name
Freedom60 Infusion Pump with Prefilled Syringe Adapter FDA UDI
Model / Reference
F10050-A FDA UDI
Description
Freedom60 Infusion Pump with Prefilled Syringe Adapter FDA UDI

Identifiers

Catalog Number
F10050-A FDA UDI
Primary DI / UDI-DI
00659443004450 FDA UDI
510(k) Number
K231918 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Ambulatory non-insulin infusion pump, mechanical, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory non-insulin infusion pump, mechanical, reusable

Koru by Repro Med Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory non-insulin infusion pump, mechanical, reusable.

Cleared under the same submission

K231918 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Repro Med Systems, Inc.

Sources (1)

  • FDA UDI c89cb250-2ccf-4101-a4f2-3588e5f95269 36 fields · synced Jun 8, 2026