Reusable SpO2 Sensors

GUDID 06941691907442

GE Datex-Ohmeda Compatible, Adult Finger Clip, 1.0M

Orantech Inc.

Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed

• Primary Device ID: 06941691907442
• NIH Device Record Key: 4a689de8-c221-4845-a4f7-3259f8169be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable SpO2 Sensors
• Version Model Number: SS-018-AF10
• Company DUNS: 544423370
• Company Name: Orantech 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941691907442 [Primary]

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: 2021-01-01
• Device Publish Date: 2020-12-24

On-Brand Devices [Reusable SpO2 Sensors]

• 06941691907442: GE Datex-Ohmeda Compatible, Adult Finger Clip, 1.0M
• 06941691907329: GE Datex-Ohmeda Compatible, Adult Finger Clip, 1.0M