WristOx2 ® Pulse Oximeter

GUDID 00849686050905

3150WB-SU, DEMOKIT, 3CT

NONIN MEDICAL, INC.

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• Primary Device ID: 00849686050905
• NIH Device Record Key: 6be4dd5d-af4a-424f-9cfb-ff5f21f51ba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WristOx2 ® Pulse Oximeter
• Version Model Number: 3150WB-SU
• Company DUNS: 174959692
• Company Name: NONIN MEDICAL, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00833166009996 [Unit of Use]
GS1	00849686050905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102350

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: 2020-12-02
• Device Publish Date: 2020-11-24

On-Brand Devices [WristOx2 ® Pulse Oximeter]

• 00849686050943: Sensor for 3150WB-SU, 15 CT BOX
• 00849686050912: SINGLE USE WRISTBAND 15 CT
• 00849686050905: 3150WB-SU, DEMOKIT, 3CT