AccessGUDID - DEVICE: ReliOn™ 2CT A1C Meter (00681131403252)

GUDID

Device Identifier (DI) Information

Brand Name: ReliOn™ 2CT A1C Meter
Version or Model: 3055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3055
Company Name: WAL-MART STORES, INC.

Primary DI Number: 00681131403252
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes.

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

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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

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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

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Storage and Handling
Special Storage Condition, Specify: Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
Special Storage Condition, Specify: f you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
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: Avoid running test on hot or cold surfaces or near sources of hot or cold.
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e5c0a13-7d3e-4899-80f4-7283f455f5c9
Public Version Date: October 14, 2021
Public Version Number: 2
DI Record Publish Date: March 30, 2021