MightySat™ Rx Fingertip Pulse Oximeter

GUDID 00843997009461

MightySat Rx Fingertip Pulse Oximeter

MASIMO CORPORATION

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00843997009461
• NIH Device Record Key: 2cbe0c10-7b65-4e1a-9290-595cdbcbe53a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MightySat™ Rx Fingertip Pulse Oximeter
• Version Model Number: 9907
• Company DUNS: 780421038
• Company Name: MASIMO 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997009461 [Primary]

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: 2022-06-17
• Device Publish Date: 2022-06-09

On-Brand Devices [MightySat™ Rx Fingertip Pulse Oximeter]

• 00843997010009: 9809
• 00843997009461: MightySat Rx Fingertip Pulse Oximeter