FDA.reportPublic FDA data

LIFEPAK CR Plus and LIFEPAK Express defibrillators

Primary DI
00883873823767
Brand
LIFEPAK CR Plus and LIFEPAK Express defibrillators
Company
PHYSIO-CONTROL, INC.
Model
80427
Catalog number
80427-000005
Device description
PACKAGE, LP EXPRESS, AUTO, CHECK FOR PULSE
Published
2019-05-01
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160012000LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery ChargerPhysio-Control, Inc.2017-12-21MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074431048PreviousGS10
00883873823767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074431048008850744310488850744310480885074431048
00883873823767008838738237678838738237670883873823767

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable public 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 automatically activates 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 applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it includes internal rechargeable batteries for energy that must be charged when not in use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Special Storage Condition, Specify00Storage at extreme temperatures of -40C to 70C (-40F to 158F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
009251992
Device count
1
Serial number
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
00883873834374CABLE, PRINTER, LP351133011330-0000142024-06-19
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
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FT1123011230-0000282025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGAN1123011230-0000272025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP351123011230-0000262025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP351123011230-0000252025-09-26

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00883873031957LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031971LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031995LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
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