DEVICE: UltraviewSL (10841522108754)

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Device Record History
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Device Identifier (DI) Information
UltraviewSL
91482
In Commercial Distribution
N/A
SPACELABS HEALTHCARE (WASHINGTON), INC
10841522108754
GS1

1
145581588 *Terms of Use
OPTION, BISX BASE MODULE, REFURB
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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?
37323 Patient monitoring system module, electroencephalographic
A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. 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 which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OLT Non-normalizing quantitative electroencephalograph software
ORT Burst suppression detection software for electroencephalograph
OMC Reduced- montage standard electroencephalograph
OLW Index-generating electroencephalograph software
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K060900 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b2b2d01e-35c6-4930-87ef-775d1915ab51
May 21, 2024
1
May 13, 2024
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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
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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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