microdot® Pro Control Solution

GUDID 00847713000794

microdot® Pro Control Solution

Cambridge Sensors USA LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00847713000794
• NIH Device Record Key: 584d18d7-e695-4bbd-9e41-fe60869933af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot® Pro Control Solution
• Version Model Number: 400-02
• Company DUNS: 962314360
• Company Name: Cambridge Sensors USA LLC
• 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: true
• 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	00847713000794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161299

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2024-10-30
• Device Publish Date: 2024-10-22

Devices Manufactured by Cambridge Sensors USA LLC

• 00847713000800 - microdot® Pro Test Strips (25ct): 2024-11-07 microdot® Pro Test Strips (25ct)
• 00847713000817 - microdot® Pro Test Strips (50ct): 2024-11-07 microdot® Pro Test Strips (50ct)
• 00847713000787 - microdot® Pro Glucometer: 2024-10-30 microdot® Pro Glucometer
• 00847713000794 - microdot® Pro Control Solution: 2024-10-30microdot® Pro Control Solution
• 00847713000794 - microdot® Pro Control Solution: 2024-10-30 microdot® Pro Control Solution
• 00847713000589 - microdot®: 2023-05-09 microdot® Pulse Oximeter
• 00847713000510 - microdot: 2022-12-06
• 00847713000398 - microdot: 2022-12-01 Nitrile powder free examination gloves.
• 00847713000411 - microdot: 2022-12-01 Nitrile powder free examination gloves.