Accu-Chek Inform II Base Unit Light 08376824190

GUDID 07613336155318

Roche Diagnostics GmbH

Metabolic profile clinical chemistry analyser IVD, stationary, automated

• Primary Device ID: 07613336155318
• NIH Device Record Key: 5d5f1b92-f2ab-44d0-ba3a-225f9ce874d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Inform II Base Unit Light
• Version Model Number: 08376824190
• Catalog Number: 08376824190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336155318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121679

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-21

On-Brand Devices [Accu-Chek Inform II Base Unit Light]

• 07613336155332: 08372284001
• 07613336155318: 08376824190
• 07613336141953: 5920353001