AccessGUDID - DEVICE: ACCU-CHEK GUIDE LINK (00365702702530)

GUDID

Device Identifier (DI) Information

Brand Name: ACCU-CHEK GUIDE LINK
Version or Model: 09651942001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09651942001
Company Name: Roche Diagnostics Operations, Inc.

Primary DI Number: 00365702702530
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 MO Replacement 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
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: 7b502ff8-49b5-4c23-b10b-4c2f3b1302f4
Public Version Date: September 14, 2023
Public Version Number: 1
DI Record Publish Date: September 06, 2023