DEVICE: Compumedics Okti (09342451002211)

Device Identifier (DI) Information

Compumedics Okti
Okti 64
In Commercial Distribution
8029-0003-01
COMPUMEDICS LIMITED
09342451002211
GS1

1
753750967 *Terms of Use
Okti 64 Channel Acquisition Module
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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?
11467 Electroencephalograph
An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
Active false
35163 Electroencephalographic ambulatory recorder
A portable electrically-powered device designed for recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders; it is not intended for inpatient monitoring. It is a small unit designed to be worn by the patient with an appropriate signal amplifier, and intended to be used with a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) data is analysed after the recording period using an appropriate computer/software.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GWQ Full-Montage Standard Electroencephalograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K230073 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

412a1177-eb49-49a4-9d92-02b70063ce9b
June 21, 2023
1
June 13, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

[?]
+61384207386
support@compumedics.com.au
1-877-294-1346
support@compumedicsusa.com
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