Accutrend Plus Meter Kit 05346754160

GUDID 00365702284104

Roche Diagnostics GmbH

Home-use/point-of-care blood glucose monitoring system IVD Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system

• Primary Device ID: 00365702284104
• NIH Device Record Key: 89213d07-7012-4346-80cf-ca9be54698ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutrend Plus Meter Kit
• Version Model Number: 05346754160
• Catalog Number: 05346754160
• 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: true
• Device Combination Product: false
• Single Use: true
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702284104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051376

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2016-09-24

On-Brand Devices [Accutrend Plus Meter Kit]

• 00365702284104: 05346754160
• 04015630946365: 07769202001