ACCU-CHEK GUIDE LINK 08109257002

GUDID 00365702702417

ACCU-CHEK GUIDE LINK MG/DL 118

Roche Diagnostics Operations, Inc.

Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use

• Primary Device ID: 00365702702417
• NIH Device Record Key: afb647eb-6f2f-426b-8828-9322753c4dd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK GUIDE LINK
• Version Model Number: 08109257002
• Catalog Number: 08109257002
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00365702702417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160017

FDA Product Code

• OZP: Automated Insulin Dosing Device System, Single Hormonal Control

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: 2023-09-29
• Device Publish Date: 2023-09-21

On-Brand Devices [ACCU-CHEK GUIDE LINK]

• 10365702738109: ACCU-CHEK GUIDE LINK REPLACEMENT KIT US
• 10365702702292: ACCU-CHEK GUIDE LINK FC US MG/DL
• 00365702702134: ACCU-CHEK GUIDE LINK MG/DL 118 (US)
• 10365702702537: Accu-Chek Guide Link MO Replacement US
• 10365702702476: Accu-Chek Guide Link SC mg/dL
• 10365702702889: ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
• 00365702702417: ACCU-CHEK GUIDE LINK MG/DL 118