SpO2 Sensor

GUDID 06944413805316

Edan Instruments, Inc.

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 06944413805316
• NIH Device Record Key: ab77b38b-b2af-450a-a3ee-f635d3be36db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Sensor
• Version Model Number: SpO2 Finger Sensor, adult, 2.5m, reusable
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: true
• Expiration Date: true
• 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	06944413805316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131818

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [SpO2 Sensor]

• 06944413805330: Wrap, Neonate,1m,reusable
• 06944413805316: SpO2 Finger Sensor, adult, 2.5m, reusable
• 06944413805293: SpO2 Finger Sensor, adult, 1m, reusable