microdot Blood Glucose meter

GUDID 05060141250554

microdot Blood glucose monitoring system

CAMBRIDGE SENSORS LTD

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• Primary Device ID: 05060141250554
• NIH Device Record Key: 5a3d0d0e-fdf2-45d8-92b8-8c75d2d5df0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot Blood Glucose meter
• Version Model Number: 100-01
• Company DUNS: 770456226
• Company Name: CAMBRIDGE SENSORS LTD
• 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: true

Customer Support Contacts

• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com
• Phone: 1-877-374-4062
• Email: info@microdotcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060141250554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070524

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-12
• Device Publish Date: 2022-04-04

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• 05060141250530 - microdot xtra meter: 2022-04-12 microdot xtra blood glucose monitoring system
• 05060141250554 - microdot Blood Glucose meter: 2022-04-12microdot Blood glucose monitoring system
• 05060141250554 - microdot Blood Glucose meter: 2022-04-12 microdot Blood glucose monitoring system