DEVICE: NA (20653405006722)
Device Identifier (DI) Information
NA
38-480-5
Not in Commercial Distribution
38-480-5
Conmed Corporation
38-480-5
Not in Commercial Distribution
38-480-5
Conmed Corporation
CABLE:BACKPAD;5 LD,CONN 49
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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? |
|---|---|---|---|---|
| 35562 | Electrocardiographic lead set, reusable |
A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IKD | CABLE, ELECTRODE |
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 Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 5 and 35 Degrees Celsius |
| Handling Environment Humidity: less than 85 Percent (%) Relative Humidity |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit |
| Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit |
| Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit |
| Handling Environment Temperature: between -20 and 55 Degrees Celsius |
| Storage Environment Temperature: between 5 and 35 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
66ab5ac6-2951-42ec-b1e7-570916776bed
October 21, 2025
3
September 16, 2020
October 21, 2025
3
September 16, 2020
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)426-6633
CustomerExperience@conmed.com
CustomerExperience@conmed.com