LIFEPAK® 1000 defibrillator

Basic Information

• Brand Name: LIFEPAK® 1000 defibrillator
• Primary DI: 00883873869581
• Version / Model: 97425
• Catalog Number: 97425-000001
• Company Name: PHYSIO-CONTROL, INC.
• Labeler DUNS: 009251992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 07734a2d-08bb-45ed-80ba-088274202d85

Device Description

USED LP1000 CONFIG UNIT1000AAAAAAAACAAAAAAAAAAA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
48049	Non-rechargeable professional 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, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883873869581	GS1

Customer Contacts

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