Model: RPO-LW-341DS50/5A
DI: 00849593025935
Status: Update
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-01-07
Current Version: 2026-05-15
Description
5 Lead Disposable GE to Pinch, 50", AHA
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
e6f3fd55-10d1-430d-848c-05f39e8da923
Distribution Status:
In Commercial Distribution
DUNS Number:
360791383
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
10849593025932
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00849593025935
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00849593025935
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61821
Name: Electrocardiographic lead set, single-use
Definition:
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 to assist electrode placement. This is a single-use device.
FDA Product Codes
DSA
Cable, Transducer And Electrode, Patient, (Including Connector)
Premarket Submissions
Submission Number:
K992524
Supplement Number:
000