WristOx2 Model 3150 with Bluetooth Low Energy

GUDID 00849686051025

Model 3150 WristOx2, BLE Wrist-Worn Pulse Oximeter

NONIN MEDICAL, INC.

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• Primary Device ID: 00849686051025
• NIH Device Record Key: 9c61e7bb-4b8e-467f-a08e-eac7578786e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WristOx2 Model 3150 with Bluetooth Low Energy
• Version Model Number: 3150
• Company DUNS: 174959692
• Company Name: NONIN MEDICAL, INC.
• Device Count: 1
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com
• Phone: 651-380-4305
• Email: alex.nelson@nonin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849686051025 [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: 2021-04-13
• Device Publish Date: 2021-04-05

Devices Manufactured by NONIN MEDICAL, INC.

• 00849686050981 - WristOx2 Model 3150SC USB Comm Cable, Philips: 2021-04-13 Model 3150SC WristOx2, USB Comm Cable, Philips
• 00849686050998 - Soft Sensor Large WO2 Model 8000SL-WO2: 2021-04-13 Model 8000SL-WO2, Soft Sensor Large WO2, Philips, Reusable Pulse Oximeter Soft Sensor
• 00849686051001 - Soft Sensor Medium WO2 Model 8000SM-WO2: 2021-04-13 Model 8000SM-WO2, Soft Sensor Medium WO2, Philips, Reusable Pulse Oximetry Soft Sensor
• 00849686051018 - Soft Sensor Small WO2 Model 8000SS-WO2: 2021-04-13 Model 8000SS-WO2, Soft Sensor Small WO2, Philips, Reusable Pulse Oximetry Soft Sensor
• 00849686051025 - WristOx2 Model 3150 with Bluetooth Low Energy: 2021-04-13Model 3150 WristOx2, BLE Wrist-Worn Pulse Oximeter
• 00849686051025 - WristOx2 Model 3150 with Bluetooth Low Energy: 2021-04-13 Model 3150 WristOx2, BLE Wrist-Worn Pulse Oximeter
• 00833166004113 - Nonin: 2020-12-10 Serial Cable, WristOx2
• 00849686070972 - Nonin: 2020-12-10 7500 Analog Cable
• 00849686072655 - Nonin: 2020-12-10 Reusable Soft Pulse Oximeter Sensor