ISA™ CO2 4494

GUDID 07350046132290

Masimo Sweden AB

Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide

Primary Device ID	07350046132290
NIH Device Record Key	a41ffc11-f5f6-4e4d-bf4d-0d93dff253b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	ISA™ CO2
Version Model Number	CO2
Catalog Number	4494
Company DUNS	632369067
Company Name	Masimo Sweden AB
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350046132290 [Primary]

FDA Product Code

CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2021-01-18
Device Publish Date	2020-05-20

On-Brand Devices [ISA™ CO2]

07350046131804	CO2 LEMO
07350046131798	CO2 ROOT
07350046131781	CO2
07350046132115	CO2
07350046132290	CO2