O3

Basic Information

• Brand Name: O3
• Primary DI: 10843997013496
• Version / Model: 4384
• Company Name: MASIMO CORPORATION
• Labeler DUNS: 780421038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-09-03
• Public Version: 2
• Public Version Date: 2021-01-18
• Public Version Status: Update
• Public Device Record Key: aacf94d7-4a86-4b8c-ab9b-6d9401ad4520

Device Description

O3 Sensor Infant/Neonatal Adhesive Sensor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUD	Oximeter, tissue saturation	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46620	Cerebral oximeter sensor, single-use	A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00843997013499	GS1
Primary	10843997013496	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182429	000