Rad-57™ Pulse CO-Oximeter™

GUDID 00843997011808

MASIMO CORPORATION

Pulse Co-oximeter

• Primary Device ID: 00843997011808
• NIH Device Record Key: 526407c8-c62a-4a86-87e0-f8392fdf5b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rad-57™ Pulse CO-Oximeter™
• Version Model Number: 3676
• 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: true
• 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	00843997011808 [Primary]
GS1	00843997013758 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080238

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 [Rad-57™ Pulse CO-Oximeter™]

• 00843997012157: 3736
• 00843997012140: 3735
• 00843997012133: 3734
• 00843997012126: 3726
• 00843997012119: 9472
• 00843997011808: 3676
• 00843997010429: 3737
• 00843997006170: 9217
• 00843997006163: 9216
• 00843997005869: 9188