AccessGUDID - DEVICE: PHILIPS HeartStart FR3 with Text and Rigid Case (00884838051430)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS HeartStart FR3 with Text and Rigid Case
Version or Model: 860363
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 860363
Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Primary DI Number: 00884838051430
Issuing Agency: GS1
Commercial Distribution End Date: January 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 079503890 *Terms of Use

Device Description: FR3 Text, US English Rigid System Bundle

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
48047	Non-rechargeable public automated external defibrillator	A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 19a3f6bd-9a63-4048-a847-a3156a0eb7ed
Public Version Date: September 14, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2014