ACCU-CHEK AVIVA COMBO

GUDID 00365702647107

ACCU-CHEK AVIVA COMBO MG/DL (670)

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

• Primary Device ID: 00365702647107
• NIH Device Record Key: bf922d9e-2c93-4bf9-9275-1b52648955c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK AVIVA COMBO
• Version Model Number: 05075645005
• 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	00365702647107 [Primary]

FDA Product Code

• LZG: Pump, Infusion, Insulin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-08

Devices Manufactured by Roche Diagnostics Operations, Inc.

• 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
• 10365702702803 - Accu-Chek Fastclix: 2023-03-30 Accu-Chek Fastclix Kit Canada
• 10365702702827 - Accu-Chek Softclix: 2023-03-30 Accu-Chek Softclix Kit Canada
• 00365702702684 - Instant White Label: 2022-10-31 IWL Lancets 10ct
• 10075537257897 - Accu-Chek Safe-T-Pro: 2022-10-27 Accu-Chek Safe-T-Pro Plus 200ct