Pronto™ Pulse CO-Oximeter®

GUDID 00843997011860

MASIMO CORPORATION

Pulse Co-oximeter

• Primary Device ID: 00843997011860
• NIH Device Record Key: 25a3b99b-627d-43c7-b188-d0aa9e7985a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pronto™ Pulse CO-Oximeter®
• Version Model Number: 4175
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997011860 [Primary]
GS1	00843997013680 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091057

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: 2018-11-30
• Device Publish Date: 2017-09-01

On-Brand Devices [Pronto™ Pulse CO-Oximeter®]

• 00843997011860: 4175
• 00843997008921: 9167