DEVICE: NIOX (07350047030519)
Device Identifier (DI) Information
NIOX
Apps / Panel
In Commercial Distribution
12-1004
Circassia AB
Apps / Panel
In Commercial Distribution
12-1004
Circassia AB
NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices.
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? |
---|---|---|---|---|
44106 | Patient health record information system application software |
An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MXA | System,Test,Breath Nitric Oxide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123683 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4e2b2d7a-8d8f-4099-8d95-b53a21ecda17
February 13, 2019
4
September 21, 2016
February 13, 2019
4
September 21, 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 |
---|---|
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
[?]
+1 (866) 275-6469
Regulatory@circassia.com
Regulatory@circassia.com