Model: T817A
DI: 08809083949136
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
43mm round, soild gel, cloth, optimal size sensor
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
42fb1fd4-3087-4de9-96b9-ce406ef3ffc2
Distribution Status:
In Commercial Distribution
DUNS Number:
688460539
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Inner box
Item #1 - Device ID:
18809083949133
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08809083949136
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08809083949136
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Carton box
Item #3 - Device ID:
28809083949130
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
18809083949133
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 35035
Name: Electrocardiographic electrode, single-use
Definition:
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.
FDA Product Codes
DRX
Electrode, Electrocardiograph
Premarket Submissions
Submission Number:
K020003
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
0
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
40
Storage Handling - Storage Handling Type:
Storage Environment Temperature