AccessGUDID - DEVICE: HeartStart (00884838038004)

GUDID

Device Identifier (DI) Information

Brand Name: HeartStart
Version or Model: FRx Infant Child Key
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803139311
Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Primary DI Number: 00884838038004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079503890 *Terms of Use

Device Description: Infant/Child Key

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?
67366	External defibrillator dose attenuation magnetic switch	A non-powered device intended to be used to magnetically activate the paediatric mode on an adult external defibrillator, in which the electrical shock energy administered is reduced during sudden cardiac arrest treatment of an infant/child. It is in the form of a magnetic plate/card/key designed to be slotted into the defibrillator before administration of the electrical shock. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d413d788-dede-432d-9c58-d14469f845c4
Public Version Date: April 30, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2014