Model: CR002-5301
DI: 06928737818146
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e87781ef-2e59-4b69-836b-f357b0a420a4
Distribution Status:
In Commercial Distribution
DUNS Number:
544519750
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06928737818146
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47487
Name: Electrical-only medical device connection cable, reusable
Definition:
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
FDA Product Codes
DSA
Cable, Transducer And Electrode, Patient, (Including Connector)
Premarket Submissions
Submission Number:
K192404
Supplement Number:
000