HeartStart

Basic Information

• Brand Name: HeartStart
• Primary DI: 00884838075849
• Version / Model: Heartstart HS1
• Catalog Number: M5066A
• Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
• Labeler DUNS: 079503890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-14
• Public Version: 5
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: 2ca640e5-0bf8-4fc5-9d25-c94264e2b320

Device Description

HeartStart Defibrillator: Includes HS1 AED, Battery, Pads (1 set), Instructions For Use, Quick Reference.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSA	Over-The-Counter Automated External Defibrillator	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47910	Non-rechargeable public semi-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 audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838075849	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity