AccessGUDID - DEVICE: ACCU-CHEK GUIDE LINK (00365702702417)

GUDID

Device Identifier (DI) Information

Brand Name: ACCU-CHEK GUIDE LINK
Version or Model: 08109257002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08109257002
Company Name: Roche Diagnostics Operations, Inc.

Primary DI Number: 00365702702417
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 LINK MG/DL 118

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:	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?
62645	Glucose analyser IVD, home-use	An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; 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. This analyser is typically included in a blood glucose monitoring system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZP	Automated Insulin Dosing Device System, Single Hormonal Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160017	110

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: afb647eb-6f2f-426b-8828-9322753c4dd3
Public Version Date: September 29, 2023
Public Version Number: 1
DI Record Publish Date: September 21, 2023