EMMA™ Kit

Basic Information

• Brand Name: EMMA™ Kit
• Primary DI: 07350046131040
• Version / Model: 3678
• Catalog Number: 3678
• Company Name: Masimo Sweden AB
• Labeler DUNS: 632369067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-11
• Public Version: 7
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: 83b78e44-4400-479a-b936-9d808a64527e

Device Description

EMMA™ 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

GMDN Terms

Code	Name	Definition	Implantable	Status
36552	Patient monitoring system module, carbon dioxide	A small unit dedicated to the measurement of carbon dioxide (CO2) content of expired gas obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or in a connected module rack. The parent device operates as a mainframe computer displaying the CO2 parameter/information measured and provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350046131040	GS1