AccessGUDID - DEVICE: A1CNow®+ Multi-UseTest System (20 count) (00381933021011)

GUDID

Device Identifier (DI) Information

Brand Name: A1CNow®+ Multi-UseTest System (20 count)
Version or Model: 3021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3021
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381933021011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: The A1CNow®+ Multi-Use 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):	Yes
Over the Counter (OTC):	No
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?
62206	Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. 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: If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, Specify: Product may be stored for a total of four months at room temperature (18-25 degrees C) anytime before the expiration date.
Special Storage Condition, Specify: If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7e54125-fc90-4ee3-8045-5e2fe2ce1056
Public Version Date: April 14, 2022
Public Version Number: 5
DI Record Publish Date: August 05, 2016