AccessGUDID - DEVICE: ACCU-CHEK GUIDE ME (00365702730106)

GUDID

Device Identifier (DI) Information

Brand Name: ACCU-CHEK GUIDE ME
Version or Model: 08499888001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Roche Diagnostics Operations, Inc.

Primary DI Number: 00365702730106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141608724 *Terms of Use

Device Description: ACCU-CHEK GUIDE ME HNP KIT MG/DL US

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):	No
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?
53301	Glucose IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: acf5e2b8-72e4-4c8a-9278-562993cdff37
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: August 27, 2019