Nonin Pulse Oximeter 20012132

GUDID D040200121321

A small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients.

WHIP-MIX CORPORATION

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• Primary Device ID: D040200121321
• NIH Device Record Key: 83667eda-ae6f-4138-9e7e-ac9bc39d363a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nonin Pulse Oximeter
• Version Model Number: 20012132
• Catalog Number: 20012132
• Company DUNS: 006385173
• Company Name: WHIP-MIX CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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
HIBCC	D040200121321 [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: 2021-06-09
• Device Publish Date: 2021-06-01

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