myPKFiT for Patients Mobile Application

Basic Information

• Brand Name: myPKFiT for Patients Mobile Application
• Primary DI: 00850025688826
• Version / Model: V2
• Company Name: Takeda Pharmaceuticals U.S.A., Inc.
• Labeler DUNS: 041877817
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-03
• Public Version: 1
• Public Version Date: 2025-01-13
• Public Version Status: New
• Public Device Record Key: 33c31460-95e3-41e6-8aec-d1a251090f3b

Device Description

Mobile application used by patients for disease management

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHY	Sparse Sample Pk Profile And Dosing Software	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61215	Home pharmaceutical management support software	A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850025688826	GS1

Premarket Submissions

Submission Number	Supplement Number
BK170028	0