AccessGUDID - DEVICE: CardioChek Plus Home Self-Test Analyzer (00381934750019)

GUDID

Device Identifier (DI) Information

Brand Name: CardioChek Plus Home Self-Test Analyzer
Version or Model: 4750
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4750
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381934750019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen.

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):	Yes
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?
62181	Multiple clinical chemistry analyser IVD, point-of-care	A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
CGA	GLUCOSE OXIDASE, GLUCOSE
NBW	System, test, blood glucose, over the counter
LBR	LDL & VLDL PRECIPITATION, HDL
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b5c173d-e7e0-4ac4-8e3f-2eecd949f876
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: April 11, 2022