AccessGUDID - DEVICE: PHILIPS HeartStart HOME (00884838076716)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS HeartStart HOME
Version or Model: 861284
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 861284
Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Primary DI Number: 00884838076716
Issuing Agency: GS1
Commercial Distribution End Date: June 10, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 079503890 *Terms of Use

Device Description: No description.

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?
48050	Home automated external defibrillator	A portable electronic device available for use by a patient/layperson outside a clinical setting to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It consists of an external pulse generator (EPG), skin-adhesive electrodes that monitor the rhythm/deliver the shocks, and a non-rechargeable battery for energy that requires replacement when indicated by the EPG.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSA	Over-the-counter automated external defibrillator

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: dfa11788-4fa8-49d5-92ab-6dadd02ee82e
Public Version Date: April 28, 2023
Public Version Number: 6
DI Record Publish Date: May 12, 2016