Device
3M™ Red Dot™ ECG Monitoring Electrodes with Soft Cloth, 2282E, 3 ea/Bag
Manufacturer
3M COMPANY
Model: 2282E Catalog: 2282E DI: 00707387789046 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-26 Current Version: 2026-05-04
Description
3M™ Red Dot™ ECG Monitoring Electrodes with Soft Cloth, 2282E, 3 ea/Bag
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 43bfed91-3338-42a3-8022-a1674c30486a
Distribution Status: In Commercial Distribution
DUNS Number: 830016148
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
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: Case
Item #1 - Device ID: 50707387789041
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 100
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00707387789046
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00707387789046
Item #2 - Device ID Type: Primary
Item #2 - 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