AccessGUDID - DEVICE: Minuteful - kidney test (17290017272471)

GUDID

Device Identifier (DI) Information

Brand Name: Minuteful - kidney test
Version or Model: MNT KDN.US.GEN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEALTHY.IO LTD

Primary DI Number: 17290017272471
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600437232 *Terms of Use

Device Description: The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

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:	Yes
Prescription Use (Rx):	Yes
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?
65242	Self-testing data clinician presentation application software IVD	An application software program designed as an Internet-based information system intended to be used by a healthcare professional to view the results of a self-test [e.g., immunochromatographic test (ICT)] performed by a patient. The software receives data from the patient’s mobile device (e.g., smartphone) application software, through a web portal, and presents the results to the healthcare professional for review and assessment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JFY	Enzymatic Method, Creatinine
KQO	Automated Urinalysis System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210069	000

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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f04a475-2f9e-4271-a614-d47f06c0fbcf
Public Version Date: November 09, 2022
Public Version Number: 1
DI Record Publish Date: November 01, 2022