FDA.reportPublic FDA data

LIFEPAK® CR Plus and LIFEPAK Express defibrillators

Primary DI
00885074440132
Brand
LIFEPAK® CR Plus and LIFEPAK Express defibrillators
Company
PHYSIO-CONTROL, INC.
Model
80403
Catalog number
80403-000148
Device description
PACKAGE,LPCR PLUS,SEMI,ENGLISH,AHA2005
Published
2014-11-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883873820506PrimaryGS10
00885074440132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883873820506008838738205068838738205060883873820506
00885074440132008850744401328850744401320885074440132

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable public semi-automated external defibrillatorA 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. The device is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries for energy that must be charged when not in use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-1142rs.seacustomersupport@physio-control.com

Regulatory Flags#

DUNS number
009251992
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883873031902LIFEPAK 35 Monitor/Defibrillator7033570335-0002242026-04-17
00883873031933LIFEPAK 35 Monitor/Defibrillator7033570335-0002262026-04-17
00883873031957LIFEPAK 35 Monitor/Defibrillator7033570335-0002272026-04-17
00883873031971LIFEPAK 35 Monitor/Defibrillator7033570335-0002282026-04-17
00883873031995LIFEPAK 35 Monitor/Defibrillator7033570335-0002292026-04-17
00883873032015LIFEPAK 35 Monitor/Defibrillator7033570335-0002302026-04-17
00883873032145LIFEPAK 35 Monitor/Defibrillator7033570335-0002312026-04-17
00883873030608LIFEPAK 15 AC Power Adapter4157741577-0003332026-02-10
07613327666656LIFEPAK 15 AC Power Adapter1114011140-0000982025-02-07
07613327673197LIFEPAK 35 Monitor/Defibrillator9933599335-000013U2025-12-18
07613327673227LIFEPAK 35 Monitor/Defibrillator9933599335-000029U2025-12-18
07613327673234LIFEPAK 35 Monitor/Defibrillator9933599335-000030U2025-12-18
07613327673241LIFEPAK 35 Monitor/Defibrillator9933599335-000033U2025-12-18
07613327673258LIFEPAK 35 Monitor/Defibrillator9933599335-000034U2025-12-18
07613327673265LIFEPAK 35 Monitor/Defibrillator9933599335-000031U2025-12-18
07613327673357LIFEPAK 35 Monitor/Defibrillator9933599335-000032U2025-12-18
07613327681864LIFEPAK 35 Monitor/Defibrillator9933599335-000028U2025-12-18
07613327691344LIFEPAK 35 Monitor/Defibrillator9633596335-000000U2025-12-18
07613327691351LIFEPAK 35 Monitor/Defibrillator9633596335-000001U2025-12-18
00883873760031BATTERY, LI-ION, LP351114111141-0001742025-09-26

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Primary DI, Brand, Company table
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