AccessGUDID - DEVICE: PTS Panels® Glucose Test Strips (25-ct) (00381931713017)

GUDID

Device Identifier (DI) Information

Brand Name: PTS Panels® Glucose Test Strips (25-ct)
Version or Model: 1713
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1713
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381931713017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand 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?
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

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 20 and 28 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight Keep dry
Storage Environment Temperature: between 68 and 82 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 420f70b2-183d-4ada-9cc7-9e3b2358e62c
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: July 15, 2016