DEVICE: SEER 1000 (04250903201080)
Device Identifier (DI) Information
SEER 1000
24 hour - CA
In Commercial Distribution
2067634-175
getemed Medizin- und Informationstechnik AG
24 hour - CA
In Commercial Distribution
2067634-175
getemed Medizin- und Informationstechnik AG
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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35162 | Electrocardiographic ambulatory recorder |
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
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FDA Product Code
[?]Product Code | Product Code Name |
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MWJ | Electrocardiograph, Ambulatory (Without Analysis) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fc6e2213-54aa-448e-9d9b-fb5bca558e2f
March 12, 2025
1
March 04, 2025
March 12, 2025
1
March 04, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined