Reusable SpO2 Sensors

GUDID 06941691907442

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

Orantech Inc.

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