DEVICE: Scio Four (04048675429333)
Device Identifier (DI) Information
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
36028 | Anaesthetic agent gas monitor, multiple |
A mains electricity (AC-powered) instrument designed for the continuous and simultaneous sampling, measuring, and display of concentrations of more than one gaseous anaesthetic agent (e.g., halothane, desflurane, Ethrane, isoflurane) in a breathing system (e.g., at an anaesthetic unit/workstation outlet or from a bedside breathing/sampling system), to ensure that appropriate agent levels are administered to a patient. It may also measure inspired and/or expired oxygen (O2) and/or carbon dioxide (CO2). Methods to determine gas concentrations include infrared (IR) spectrometry, ultraviolet (UV) absorption, interferometry, and ultrasound.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K051628 | 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
45f5c484-995e-4361-b2b5-50e5822730f2
July 06, 2018
3
November 04, 2015
July 06, 2018
3
November 04, 2015
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
[?]
+494518820
info@draeger.com
info@draeger.com