AccessGUDID - DEVICE: Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) (00381934752013)

GUDID

Device Identifier (DI) Information

Brand Name: Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)
Version or Model: REF 4752
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REF 4752
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381934752013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
53354	Multiple lipid analyte IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen, using a spectrophotometry method. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	Active	false
52848	Multiple lipid analyte IVD, kit, multiple technologies	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to produce a lipid profile, using a number of different technologies on a single analyser. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, test, blood glucose, over the counter
CGA	GLUCOSE OXIDASE, GLUCOSE
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
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
Special Storage Condition, Specify: Keep away from sunlight Keep dry
Storage Environment Temperature: between 68 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d50a5f7c-b6b1-4df5-8e31-e7a1179462f8
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: June 01, 2023