ACCU-CHEK GUIDE

Basic Information

• Brand Name: ACCU-CHEK GUIDE
• Primary DI: 00365702702066
• Version / Model: 07400942001
• Catalog Number: 07400942001
• Company Name: Roche Diagnostics Operations, Inc.
• Labeler DUNS: 141608724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 4
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: 96ee2869-4f5b-42c7-90bd-9d4b254d2f05

Device Description

ACCU-CHEK GUIDE METER ONLY MG/DL US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00365702702066	GS1
Package	10365702702063	GS1		20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K160944	000