AccessGUDID - DEVICE: myPKFiT for Healthcare Professionals (00850025688819)

GUDID

Device Identifier (DI) Information

Brand Name: myPKFiT for Healthcare Professionals
Version or Model: V3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Takeda Pharmaceuticals U.S.A., Inc.

Primary DI Number: 00850025688819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041877817 *Terms of Use

Device Description: Web application used by Healthcare Professionals to generate dose calculations

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHY	Sparse Sample Pk Profile And Dosing Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK170028	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f99333d-a747-4f9f-86bd-9cd9f9f15ff9
Public Version Date: January 13, 2025
Public Version Number: 1
DI Record Publish Date: January 03, 2025