AccessGUDID - DEVICE: Well at Walgreens (00311917169835)

GUDID

Device Identifier (DI) Information

Brand Name: Well at Walgreens
Version or Model: 3056
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3056
Company Name: WALGREEN CO.

Primary DI Number: 00311917169835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: The Walgreens At-Home A1C Test Kit 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
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Special Storage Condition, Specify: Avoid running test on hot or cold surfaces or near sources of hot or cold.
Special Storage Condition, Specify: If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
Special Storage Condition, Specify: Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
Special Storage Condition, Specify: Do not use if dot is red or if the product is past the expiration date.
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: 3242203b-2f5f-44f8-9f72-9b996a1d7937
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 15, 2016