AccessGUDID - DEVICE: PTS Panels® CHOL+HDL+GLU Test Strips (00381932412018)

GUDID

Device Identifier (DI) Information

Brand Name: PTS Panels® CHOL+HDL+GLU Test Strips
Version or Model: 2412
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2412
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381932412018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL Cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA 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):	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?
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
CGA	GLUCOSE OXIDASE, GLUCOSE
LBR	LDL & VLDL PRECIPITATION, HDL
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
NBW	System, test, blood glucose, over the counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162282	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 20 and 28 Degrees Celsius
Storage Environment Temperature: between 68 and 82 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3cd28941-7570-4e1a-960b-9f9dff557a45
Public Version Date: July 31, 2023
Public Version Number: 6
DI Record Publish Date: July 15, 2016