DEVICE: IRMA™ AX+ (07350046131712)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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. |
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6c3eea7d-d85b-41a1-92b8-7b355afcbf2f
July 06, 2018
3
August 11, 2016
July 06, 2018
3
August 11, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined