Masimo Compatible Disposable SpO2 Sensor, Neonate

GUDID B817102081

CABLES AND SENSORS, LLC

Pulse oximeter probe, single-use

• Primary Device ID: B817102081
• NIH Device Record Key: 41d3cb2a-c912-41e0-a856-5bdcbe5b2b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masimo Compatible Disposable SpO2 Sensor, Neonate
• Version Model Number: 10208
• Company DUNS: 040814020
• Company Name: CABLES AND SENSORS, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B817102080 [Primary]
HIBCC	B817102081 [Package]; Contains: B817102080; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181270

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: 2019-12-19
• Device Publish Date: 2019-12-11

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