LIFEPAK 15 monitor/defibrillator

Basic Information

• Brand Name: LIFEPAK 15 monitor/defibrillator
• Primary DI: 00883873808221
• Version / Model: 97577
• Catalog Number: 97577-000100
• Company Name: PHYSIO-CONTROL, INC.
• Labeler DUNS: 009251992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-07
• Public Version: 2
• Public Version Date: 2020-05-18
• Public Version Status: Update
• Public Device Record Key: df0a4c40-e944-43e6-8f8a-6d1bc6108d5f

Device Description

15AABBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB

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: 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
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
17882	Physiologic-monitoring defibrillation system	An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883873808221	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160026	001
P160026	004
P160026	009

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Recommended storage temperature is -20 to 65 celsius (-4 to 140 Fahrenheit) except therapy electrodes and batteries.
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity