FDA.reportPublic FDA data

myPKFiT for Patients Mobile Application

Primary DI
00850025688826
Brand
myPKFiT for Patients Mobile Application
Company
Takeda Pharmaceuticals U.S.A., Inc.
Model
V2
Device description
Mobile application used by patients for disease management
Published
2025-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PHYSparse Sample Pk Profile And Dosing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHYSparse Sample Pk Profile And Dosing SoftwareAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1700280

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1700280

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025688826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025688826008500256888268500256888260850025688826

GMDN Terms#

Term, Definition table
TermDefinition
Home pharmaceutical management support softwareA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041877817
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025688963HyHub Duo Vial Access Device652008365200832025-09-23
00850025688291HyHub Vial Access Device550022255002222025-09-23
00198815000107Recombinant Factor VIII Substrate, Porcine Sequence652175365217532025-08-01
00850025688819myPKFiT for Healthcare ProfessionalsV32025-01-03
00850025688871BAXJECT II Hi-Flow34007692024-06-12
00850025688864BAXJECT II650781665078162024-02-29
00850025688888Anti-Drug Antibody Biomarker Specimen Collection Kit500083350008332023-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025688819myPKFiT for Healthcare ProfessionalsTakeda Pharmaceuticals U.S.A., Inc.PHY2025-01-03