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myPKFiT for Patients Mobile Application

FDA UDI

Class II (US FDA UDI)

by Takeda Pharmaceuticals U.S.A., Inc.

Identity

Trade Name
myPKFiT for Patients Mobile Application FDA UDI
Generic Name
Home pharmaceutical management support software FDA UDI
Device Name
Mobile application used by patients for disease management FDA UDI
Model / Reference
V2 FDA UDI
Description
Mobile application used by patients for disease management FDA UDI

Identifiers

Primary DI / UDI-DI
00850025688826 FDA UDI
FDA Product Code
PHY FDA UDI
GMDN Term
Home pharmaceutical management support software 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Home pharmaceutical management support software

myPKFiT for Patients Mobile Application by Takeda Pharmaceuticals U.S.A., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home pharmaceutical management support software.

Cleared under the same submission

BK170028 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Takeda Pharmaceuticals U.S.A., Inc.

Sources (1)

  • FDA UDI 33c31460-95e3-41e6-8aec-d1a251090f3b 34 fields · synced Jun 8, 2026