DEVICE: SPO2 MASIMOSET POD SET KAPPA (04049098004961)
Device Identifier (DI) Information
SPO2 MASIMOSET POD SET KAPPA
MS16902
In Commercial Distribution
DRAEGER MEDICAL SYSTEMS, INC.
MS16902
In Commercial Distribution
DRAEGER MEDICAL SYSTEMS, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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36554 | Patient monitoring system module, pulse oximetry |
A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. 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 in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DQA | Oximeter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K061329 | 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
6f60861c-d338-4002-897d-524f94214313
July 06, 2018
3
October 24, 2015
July 06, 2018
3
October 24, 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 |
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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
[?]
+18004372437
info@draeger.com
info@draeger.com