MOBI

GUDID 10891040000306

Smart Finger Tip Pulse Oximeter

MOBI TECHNOLOGIES, INC.

Pulse oximeter

• Primary Device ID: 10891040000306
• NIH Device Record Key: c03583ae-b1ec-4f87-aa46-c4829c1229ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOBI
• Version Model Number: 700030
• Company DUNS: 137468570
• Company Name: MOBI TECHNOLOGIES, 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00891040000309 [Primary]
GS1	10891040000306 [Package]; Contains: 00891040000309; Package: Cardboard [6 Units]; In Commercial Distribution
GS1	20891040000303 [Package]; Package: Cardboard [24 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-08
• Device Publish Date: 2022-07-31

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• 20891040701217: Prime Ear and Forehead Thermometer.
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