Pulse Oximeter

GUDID 00817746021233

BETTER BASICS, INC.

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00817746021233
• NIH Device Record Key: b80aa21c-27fd-4a70-8456-bc7687e42cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Oximeter
• Version Model Number: MP-OX300
• 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: 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	00817746021226 [Primary]
GS1	00817746021233 [Package]; Contains: 00817746028874; Package: [100 Units]; In Commercial Distribution
GS1	00817746028874 [Package]; Contains: 00817746021226; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140582

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-15

On-Brand Devices [Pulse Oximeter]

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