Accu-Chek Aviva

GUDID 00365702702394

ACCU-CHEK AVIVA MG/DL 455 US NON-VA

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: 00365702702394
• NIH Device Record Key: c1e489fc-be96-41cb-9d97-2f815f1cdac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Aviva
• Version Model Number: 08340331001
• 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	00365702702394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133862

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

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: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [Accu-Chek Aviva]

• 00365702725102: ACCU-CHEK AVIVA PLUS METER ONLY US
• 10365702724102: ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE
• 00365702723108: Accu-Chek Aviva Plus Retail Kit 10/case
• 00365702544109: ACCU-CHEK AVIVA MG/DL 455 US
• 00365702107106: ACCU-CHEK AVIVA 2 LEVEL CONTROL 6/CS
• 00365702702394: ACCU-CHEK AVIVA MG/DL 455 US NON-VA