Nonagon N9+ SmartExam

GUDID 27290018446151

NONAGON LTD

Pulse oximeter

• Primary Device ID: 27290018446151
• NIH Device Record Key: 0167ed43-0b03-4f3c-898d-5f9cae5ea7db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nonagon N9+ SmartExam
• Version Model Number: N9+
• Company DUNS: 532283903
• Company Name: NONAGON LTD
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	27290018446151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202483

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: 2022-10-06
• Device Publish Date: 2022-09-28

Devices Manufactured by NONAGON LTD

• 17290018446154 - Nonagon N9+: 2022-10-06
• 27290018446151 - Nonagon N9+ SmartExam: 2022-10-06
• 27290018446151 - Nonagon N9+ SmartExam: 2022-10-06
• 07290018446126 - N9 speculum: 2021-09-21 ENT ear speculum for Nonagon N9 device
• 07290018446102 - Nonagon: 2021-06-03 The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a ded