AccessGUDID - DEVICE: Equate Blood Glucose Test Strips (00681131104869)

GUDID

Device Identifier (DI) Information

Brand Name: Equate Blood Glucose Test Strips
Version or Model: 038600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 038600
Company Name: Unistrip Technologies, LLC

Primary DI Number: 00681131104869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 043251054 *Terms of Use

Device Description: Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.

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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 215d2f11-b06a-4575-bb52-706f97cd61a8
Public Version Date: September 27, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00681131304863	24	00681131104869	2020-02-05	Not in Commercial Distribution	Corrugated Carton
30681131104860	1	00681131104869		In Commercial Distribution	Vial
10681131104866	24	00681131104869		In Commercial Distribution	Corrugated Carton