microdot®

GUDID 00847713000589

microdot® Pulse Oximeter

Cambridge Sensors USA LLC

Pulse oximeter

• Primary Device ID: 00847713000589
• NIH Device Record Key: dceff118-5e9a-4c5d-90e4-a2f736a03459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot®
• Version Model Number: 1000-100
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847713000572 [Primary]
GS1	00847713000589 [Package]; Contains: 00847713000572; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

FDA Product Code

• DQA: Oximeter

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: 2023-05-09
• Device Publish Date: 2023-05-01

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: 2024-10-30 microdot® Pro Control Solution
• 00847713000589 - microdot®: 2023-05-09microdot® Pulse Oximeter
• 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.