FDA.report

LIFEPAK CR Plus and LIFEPAK Express defibrillators

Primary DI
00721902508158
Brand
LIFEPAK CR Plus and LIFEPAK Express defibrillators
Company
PHYSIO-CONTROL, INC.
Model
80403
Catalog number
80403-000021
Device description
PACKAGE,LP CR PLUS,AUTO,CIRCULATION
Published
2018-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00721902508158PrimaryGS10
00883873820452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902508158007219025081587219025081580721902508158
00883873820452008838738204528838738204520883873820452

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)442-1142rs.seacustomersupport@stryker.com

Regulatory Flags

DUNS number
009251992
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00883873030608LIFEPAK 15 AC Power Adapter4157741577-0003332026-02-10
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
00883873760048SHIP KIT, POWER SUPPLY, LP354133541335-0000032025-09-26
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
00883873760475CHARGER, BATTERY, LP351114011140-0001322025-09-26
00883873760482BATTERY, LI-ION, WITH IFU, LP351133511335-0000092025-09-26
00883873760499ASSY, CABLE, ECG, 5WIRE, AHA, 8FT1111111111-0000582025-09-26

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