InPen Smart Insulin Delivery System

FDA UDI

Class II (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name: InPen Smart Insulin Delivery System FDA UDI
Generic Name: Empty self-injector, mechanical FDA UDI
Device Name: SOFTWARE MMT-8061 INS PEN ANDROID APP FDA UDI
Model / Reference: MMT-8061 FDA UDI
Description: SOFTWARE MMT-8061 INS PEN ANDROID APP FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000489960 FDA UDI
510(k) Number: K190487 FDA UDI
K242775 FDA UDI
FDA Product Code: NDC FDA UDI
GMDN Term: Empty self-injector, mechanical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Empty self-injector, mechanical

InPen Smart Insulin Delivery System by Medtronic Minimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Empty self-injector, mechanical.

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Omnitrope® Pen 5 — Sandoz Inc. · Class II
NovoPen Echo® — NOVO NORDISK INC. · Class II
Omnitrope® Pen 10 — Sandoz Inc. · Class II
InPen Smart Insulin System — COMPANION MEDICAL, INC. · Class II

Cleared under the same submission

K190487 also covers:

InPen Smart Insulin Delivery System — MEDTRONIC MINIMED, INC.

K242775 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic Minimed, Inc.

Sources (1)

FDA UDI 4209dbf7-deaa-4436-9fb2-b82be3d13f2b 35 fields · synced May 30, 2026