microdot®

GUDID 00847713000589

microdot® Pulse Oximeter

Cambridge Sensors USA LLC

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter 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

• 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.
• 00847713000435 - microdot: 2022-12-01 Nitrile powder free examination gloves.
• 00847713000558 - microdot: 2022-12-01 Nitrile powder free examination gloves.