DEVICE: ISA™ OR+ (07350046131835)

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Device Identifier (DI) Information
ISA™ OR+
OR+ LEMO
In Commercial Distribution

Masimo Sweden AB
07350046131835
GS1

1
632369067 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37061 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6e317bd9-3bc2-4d1a-a0fc-d8c211bb8432
December 06, 2021
5
August 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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