AccessGUDID - DEVICE: CardioChek® PA analyzer (00381931708013)

GUDID

Device Identifier (DI) Information

Brand Name: CardioChek® PA analyzer
Version or Model: 1708
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1708
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381931708013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. 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):	Yes
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
NAQ	LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER
CGA	GLUCOSE OXIDASE, GLUCOSE
LBR	LDL & VLDL PRECIPITATION, HDL
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES
NGO	TEST, TRIGLYCERIDES, OVER THE COUNTER
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151545	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
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1dcd3887-44f6-4bc6-a327-55d21faf0914
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: July 15, 2016