DEVICE: SEER 1000 ECG Cable (04250903200779)
Device Identifier (DI) Information
SEER 1000 ECG Cable
5 Leads (2 Channels), 105 cm (41 in), IEC Color Code
In Commercial Distribution
2067634-015
getemed Medizin- und Informationstechnik AG
5 Leads (2 Channels), 105 cm (41 in), IEC Color Code
In Commercial Distribution
2067634-015
getemed Medizin- und Informationstechnik AG
The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
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? |
---|---|---|---|---|
35562 | Electrocardiographic lead set, reusable |
A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.
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Active | false |
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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K130785 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Dry |
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -25 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e1dcbb6f-8bc6-4174-a9be-3a0b8f42a7ad
July 06, 2018
3
September 21, 2016
July 06, 2018
3
September 21, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49332939420
info@getemed.de
info@getemed.de