HeartStart

Basic Information

• Brand Name: HeartStart
• Primary DI: 00884838055728
• Version / Model: FR3 Fast Response Kit
• Catalog Number: 989803150111
• 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: 2023-04-06
• Public Version: 3
• Public Version Date: 2024-01-31
• Public Version Status: Update
• Public Device Record Key: 43e00974-0b70-4eb7-a57a-65947e0b0e27

Device Description

Fast Response Kit, FR3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	868.5570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35693	Cardiopulmonary resuscitation kit, single-use	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838055728	GS1

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 – 90 Percent (%) Relative Humidity