ISA AX + Root

Basic Information

• Brand Name: ISA AX + Root
• Primary DI: 00843997012904
• Version / Model: 4376
• Company Name: MASIMO CORPORATION
• Labeler DUNS: 780421038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-03
• Public Version: 1
• Public Version Date: 2020-07-13
• Public Version Status: New
• Public Device Record Key: 0ae78b95-2581-4cad-b25e-fef4e32f94fe

Device Description

ISA AX + Root and Mounting Bracket Kit ISA Sidestream Analyzer and Mounting Bracket for use with Root

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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
36757	Patient monitoring system module rack	A device typically designed as a framework or specially constructed holder where module devices used with a patient monitoring system can be plugged in and connected to the parent device usually by one cable. This device is typically used to facilitate connection to the patient from the modules using standard length cables and leads when the parent device is situated away from the patient (out of reach), e.g., the parent device may be mounted to a wall support or a ceiling pendant arm (Utility supply system).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843997012904	GS1

Customer Contacts

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

Storage Conditions

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