Device
Standard-length leadset for Stress system. 10-lead, IEC color-coding, grabbers
Manufacturer
Philips Medizin Systeme Böblingen GmbH
Philips Medizin Systeme Böblingen GmbH
Model: 12L Leadset, Grabber, IEC
Catalog: 989803180131
DI: 00884838117402
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Standard-length leadset for Stress system. 10-lead, IEC color-coding, grabbers
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
20fb8d3c-2fa7-414f-8150-de237e441fd0
Distribution Status:
In Commercial Distribution
DUNS Number:
314101143
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00884838117402
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35562
Name: Electrocardiographic lead set, reusable
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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.
FDA Product Codes
DQK
Computer, Diagnostic, Programmable
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
50
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
57.2
Item #2 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling High - @attributes - Value:
101.4
Item #2 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
10
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
90
Item #3 - Storage Handling Type:
Storage Environment Humidity