AccessGUDID - DEVICE: A1CNow® Self Check Test System (00381933030013)

GUDID

Device Identifier (DI) Information

Brand Name: A1CNow® Self Check Test System
Version or Model: 3030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3030
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381933030013
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2019
Device Count: 2
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.

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?
62205	Glycated haemoglobin (HbA1c) monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090413	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: Do not use if dot is red or if the product is past the expiration date.
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e6e5450-8a97-4fbe-b048-ce7e09707c5e
Public Version Date: April 13, 2022
Public Version Number: 5
DI Record Publish Date: August 05, 2016