myPKFiT for Patients Mobile Application

GUDID 00850025688826

Mobile application used by patients for disease management

Takeda Pharmaceuticals U.S.A., Inc.

Home pharmaceutical management support software

• Primary Device ID: 00850025688826
• NIH Device Record Key: 33c31460-95e3-41e6-8aec-d1a251090f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myPKFiT for Patients Mobile Application
• Version Model Number: V2
• Company DUNS: 041877817
• Company Name: Takeda Pharmaceuticals U.S.A., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025688826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170028

FDA Product Code

• PHY: Sparse Sample Pk Profile And Dosing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

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

• 00850025688819 - myPKFiT for Healthcare Professionals: 2025-01-13 Web application used by Healthcare Professionals to generate dose calculations
• 00850025688826 - myPKFiT for Patients Mobile Application: 2025-01-13Mobile application used by patients for disease management
• 00850025688826 - myPKFiT for Patients Mobile Application: 2025-01-13 Mobile application used by patients for disease management
• 00850025688871 - BAXJECT II Hi-Flow: 2024-06-20 Needleless Transfer Device
• 00850025688864 - BAXJECT II: 2024-03-08 Needleless Transfer Device
• 00850025688888 - Anti-Drug Antibody Biomarker Specimen Collection Kit: 2023-11-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectings