DEVICE: ECG Cables and Leadsets (20884838006762)
Device Identifier (DI) Information
ECG Cables and Leadsets
Preattached Leadwire electrode, Medium
In Commercial Distribution
989803100511
Philips Medical Systems Hsg
Preattached Leadwire electrode, Medium
In Commercial Distribution
989803100511
Philips Medical Systems Hsg
Preattached Leadwire electrode, Medium Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket rectangular 33cm x 22cm cloth backingwith Ag/AgCl sensor, 3/pouch, 300/case.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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? |
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35035 | Electrocardiographic electrode, single-use |
A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRY | MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS |
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 45 Degrees Celsius |
Storage Environment Humidity: between 0 and 100 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3a7a85a6-295d-414d-a435-5f002456c583
June 04, 2024
11
December 27, 2016
June 04, 2024
11
December 27, 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 |
---|---|---|---|---|---|
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:
10884838006765
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(999)999-9999
xx@xx.xx
xx@xx.xx