NuvoMed

GUDID 00859811009258

Audible Fingertip Pulse Oximeter

NUVOMED, INC.

Pulse oximeter, line-powered

• Primary Device ID: 00859811009258
• NIH Device Record Key: a13144a0-899f-400a-8641-43a5077eb8af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuvoMed
• Version Model Number: TOS-6/0925
• Company DUNS: 080809709
• Company Name: NUVOMED, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859811009258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191430

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: 2020-11-09
• Device Publish Date: 2020-10-30

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• 00859811007384: Arm Blood Pressure (Non-app)
• 00859811007377: Wrist Blood Pressure
• 00859811007360: Infrared Thermometer (Non-app)
• 00859811007261: Glucose Test Strip (Non-apps)
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• 00859811007025: Wireless Infrared Thermometer
• 00859811007018: Automatic Blood Pressure Monitor
• 00859811007001: Wireless Finger Oxygen Saturation Monitor
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• 00810110303508: Arm Blood Pressure Monitor
• 00810110303492: Wrist Blood Pressure Monitor