Accu-Chek Guide

GUDID 10365702728100

Accu-Chek Guide Sample Kit FCN mg/dl US

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry

• Primary Device ID: 10365702728100
• NIH Device Record Key: eaab8c47-9073-4ea4-8b13-756e62574ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Guide
• Version Model Number: 08453063001
• Company DUNS: 141608724
• Company Name: Roche Diagnostics Operations, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702728103 [Primary]
GS1	10365702728100 [Package]; Contains: 00365702728103; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160944

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-01

On-Brand Devices [Accu-Chek Guide]

• 00365702729100: Accu-Chek Guide Retail Kit FCN mg/dl US
• 10365702728100: Accu-Chek Guide Sample Kit FCN mg/dl US
• 10365702726106: Accu-Chek Guide Mail Order 50 ct
• 00365702719101: Accu-Chek Guide 50ct HN 36/cs
• 00365702712102: ACCU-CHEK GUIDE 100CT STRIP 24/CS
• 00365702710108: Accu-Chek Guide 25ct Strip 36/cs
• 00365702702066: ACCU-CHEK GUIDE METER ONLY MG/DL US
• 00365702702042: ACCU-CHEK GUIDE RETAIL KIT MG/DL
• 10365702702032: ACCU-CHEK GUIDE SAMPLE KIT MG/DL
• 00365702701977: ACCU-CHEK GUIDE 10CT STRIP 36/CS
• 00365702701953: ACCU-CHEK GUIDE 50CT STRIP 36/CS
• 00365702701908: VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE
• 00365702688100: ACCU-CHEK GUIDE 2-LEVEL CONTROLS US
• 00365702609105: ACCU-CHEK GUIDE MG/DL METER 923 (US)