AccessGUDID - DEVICE: HeartStart (00884838002784)

GUDID

Device Identifier (DI) Information

Brand Name: HeartStart
Version or Model: 7-Wire Lead Set for 12-lead use IEC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M3529A
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838002784
Issuing Agency: GS1
Commercial Distribution End Date: February 04, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Additional 7-Wire Lead Set for 12 Lead (IEC)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35562	Electrocardiographic lead set, reusable	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRO	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
MKJ	Automated External Defibrillators (Non-Wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62572081-31de-4830-a595-884ce55cc495
Public Version Date: September 16, 2024
Public Version Number: 7
DI Record Publish Date: March 27, 2017