Accu-Chek Inform II Base Unit Light 5984840001

GUDID 07613336141953

Roche Diagnostics GmbH

Metabolic profile clinical chemistry analyser IVD, stationary, automated

• Primary Device ID: 07613336141953
• NIH Device Record Key: cffc0041-ccda-47e2-a7b2-8882523ae4a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Inform II Base Unit Light
• Version Model Number: 5920353001
• Catalog Number: 5984840001
• 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: 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336141953 [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: 2016-09-20

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

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