Pulse oximeter

GUDID 00817746020151

BETTER BASICS, INC.

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• Primary Device ID: 00817746020151
• NIH Device Record Key: 40cfb1fa-25dc-4d9b-938a-60d000857cf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse oximeter
• Version Model Number: MP-OX150-US
• Company DUNS: 013029698
• Company Name: BETTER BASICS, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817746020151 [Primary]
GS1	00817746020168 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00817746020175 [Package]; Contains: 00817746020168; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-18

On-Brand Devices [Pulse oximeter]

• 00817746021233: MP-OX300
• 00817746020212: MP-OX250-US
• 00817746020182: MP-OX200-US
• 00817746020151: MP-OX150-US