AccessGUDID - DEVICE: ReliOn™ Premier Blood Glucose Test Strips (00681131169776)

GUDID

Device Identifier (DI) Information

Brand Name: ReliOn™ Premier Blood Glucose Test Strips
Version or Model: 780050 / 780100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WAL-MART STORES, INC.

Primary DI Number: 00681131169776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blood glucose meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The ReliOn Premier family of blood glucose monitoring systems are intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. They are not intended for use on neonates, and they are not for the diagnosis or screening of 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:	No
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?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose 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. 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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121133	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 34 and 86 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 938e0daa-9757-44dc-8482-c57a26203272
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 14, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20681131169817	60	10681131169810	In Commercial Distribution	Master Case
10681131169810	6	00681131169813	In Commercial Distribution	Case Shipper
00681131169813	2	00681131169776	In Commercial Distribution	Carton
20681131169770	45	10681131169773	In Commercial Distribution	Master Case
10681131169773	12	00681131169776	In Commercial Distribution	Case Shipper