ACCU-CHEK GUIDE 10436271001

GUDID 00365702703209

VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE

Roche Diagnostics Operations, Inc.

Glucose IVD, reagent

• Primary Device ID: 00365702703209
• NIH Device Record Key: 3dbbda55-a75d-471f-956d-944620dc2cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK GUIDE
• Version Model Number: 10436271001
• Catalog Number: 10436271001
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00365702703209 [Primary]

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: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by Roche Diagnostics Operations, Inc.

• 00365702703209 - ACCU-CHEK GUIDE: 2025-03-28VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE
• 00365702703209 - ACCU-CHEK GUIDE: 2025-03-28 VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE
• 10365702703213 - ACCU-CHEK GUIDE: 2025-03-28 ACCU-CHEK GUIDE CASH VALUE KIT
• 10365702703237 - ACCU-CHEK GUIDE: 2025-03-28 ACCU-CHEK GUIDE CASH US 30CT STRIP
• 10365702703251 - ACCU-CHECK GUIDE: 2025-03-28 ACCU-CHEK GUIDE CASH US 60CT STRIP
• 00365702702417 - ACCU-CHEK GUIDE LINK: 2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118
• 10365702702889 - ACCU-CHEK GUIDE LINK: 2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
• 10365702702476 - ACCU-CHEK GUIDE LINK: 2023-09-14 Accu-Chek Guide Link SC mg/dL
• 10365702702537 - ACCU-CHEK GUIDE LINK: 2023-09-14 Accu-Chek Guide Link MO Replacement US