Wireless Pulse Oximeter

GUDID 00867661000356

CLOUD DX INC.

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• Primary Device ID: 00867661000356
• NIH Device Record Key: 2c88de82-5ba7-4860-9538-7aaa7ca61183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wireless Pulse Oximeter
• Version Model Number: WPO-10B
• Company DUNS: 079659378
• Company Name: CLOUD DX 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: true
• Manufacturing Date: false
• 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: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com
• Phone: 888-543-0944
• Email: regulatory@CloudDX.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867661000356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170965

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-06-05

On-Brand Devices [Wireless Pulse Oximeter]

• 00867661000349: WPO-10
• 00867661000356: WPO-10B