AccessGUDID - DEVICE: IRMA™ AX+ (07350046131712)

GUDID

Device Identifier (DI) Information

Brand Name: IRMA™ AX+
Version or Model: AX+
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Masimo Sweden AB

Primary DI Number: 07350046131712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 632369067 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Patient monitoring system module, multiple-gas	A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air 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 system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.

GMDN Preferred Term Name

GMDN Definition

Patient monitoring system module, multiple-gas

A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air 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 system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.

FDA Product Code

[?]

Product Code	Product Code Name
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123043	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c3eea7d-d85b-41a1-92b8-7b355afcbf2f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 11, 2016