ISA OR+

Basic Information

• Brand Name: ISA OR+
• Primary DI: 00843997009317
• Version / Model: 9685
• Company Name: MASIMO CORPORATION
• Labeler DUNS: 780421038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-16
• Public Version: 1
• Public Version Date: 2022-03-24
• Public Version Status: New
• Public Device Record Key: 9d0464ee-0870-4e03-9fa3-377f67122154

Device Description

ISA OR+ and Mounting Bracket Kit

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12662	Respiration monitor	A mains electricity (AC-powered) bedside device designed to measure and display a non-ambulatory patient's respiratory functions. Measurements include concentration of respiratory gas components [e.g., carbon dioxide (CO2), oxygen (O2)] and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea). The device may also measure airway pressure (Paw) and oesophageal pressure (Pes). It is typically equipped with audible and/or visual alarms that are triggered when respiratory parameters drop below or exceed pre-set limits.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843997009317	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 100 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius