AccessGUDID - DEVICE: QwikCheck Test Strips (07290012140167)

GUDID

Device Identifier (DI) Information

Brand Name: QwikCheck Test Strips
Version or Model: 0700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0700
Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Primary DI Number: 07290012140167
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514680529 *Terms of Use

Device Description: No description.

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):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, Differential Cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063864	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a5b9f34-1877-4cf3-bcd3-6ec2c506d26b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016