SpO2 Sensor

GUDID 06944413805316

Edan Instruments, Inc.

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