DEVICE: MR Patient Care Single Patch ECG Electrodes (25) (10884838101927)
Device Identifier (DI) Information
MR Patient Care Single Patch ECG Electrodes (25)
Single Patch ECG Electrodes (25)
Not in Commercial Distribution
989803179031
Philips Ds North America LLC
Single Patch ECG Electrodes (25)
Not in Commercial Distribution
989803179031
Philips Ds North America LLC
QUADTRODE MRI ECG PAD,25/BOX
Device Characteristics
MR Conditional | |
No | |
No | |
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? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRX | Electrode, Electrocardiograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 32 Degrees Celsius |
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure: between 570 and 1020 millibar |
Storage Environment Atmospheric Pressure: between 429 and 765 Millimeter of Mercury |
Storage Environment Humidity: between 5 and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 57 and 102 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 99.000 Millimeter |
Width: 99.000 Millimeter |
Device Record Status
ad3cfcd0-35fb-4b16-8797-8b86760cd679
June 16, 2025
9
May 18, 2021
June 16, 2025
9
May 18, 2021
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00884838101920
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(999)999-9999
xx@xx.xx
xx@xx.xx