Model: DLSRPHP5L6F
DI: B631DLSRPHP5L6F1
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5bffdb6f-16d6-4c38-afbf-90b76fe46231
Distribution Status:
In Commercial Distribution
DUNS Number:
078861998
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B631DLSRPHP5L6F1
Type:
Primary
Issuing Agency:
HIBCC
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
IKD
Cable, Electrode