DEVICE: Ultraview SL® (10841522106293)
Device Identifier (DI) Information
Ultraview SL®
Ultraview SL®
In Commercial Distribution
91424-A
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview SL®
In Commercial Distribution
91424-A
SPACELABS HEALTHCARE (WASHINGTON), INC
BASE UNIT, SVO2/SCVO2 MODULE,91424
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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37172 | Patient monitoring system module, intracardiac oximetry |
A small unit designed to measure the ratio of oxyhaemoglobin (O2Hb) to reduced haemoglobin (RHb) and/or deoxyhaemoglobin (HHb) within the heart by comparing the absorption of red and infrared light in the blood [mixed venous oxygen saturation (SvO2)]. A fibreoptic probe is inserted into the pulmonary artery, often a Swan-Ganz catheter, to detect the SvO2 levels. It is designed to operate as part of a patient monitoring system enhancing the function of this parent device. The module automatically plugs into the parent device when placed into a standardized slot in the parent device which then operates as a mainframe computer displaying the SvO2 information measured 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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K893867 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f455ca58-c9ac-433b-afd3-0d8d5fc734d7
October 26, 2023
6
September 28, 2016
October 26, 2023
6
September 28, 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 |
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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
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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