LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507-000132

GUDID 00883873852804

Pkg LP20e CMM,PCNG,SpO2,AHA USAS,ENG

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system Physiologic-monitoring defibrillation system Physiologic-monitoring defibrillation system Physiologic-monitoring defibrillation system
Primary Device ID00883873852804
NIH Device Record Keyd6e7a68f-2b7c-4f20-82b1-e214263661a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFEPAK 20 and LIFEPAK 20e defibrillator/monitors
Version Model Number99507
Catalog Number99507-000132
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Storage at extreme temperatures of -20 to 60 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage at extreme temperatures of -20 to 60 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage at extreme temperatures of -20 to 60 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873852804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-21
Device Publish Date2019-06-13

On-Brand Devices [LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors]

00721902665301LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
00721902665233LP20-CONFIGURED,WITH PACING,ENGLISH
00721902665103LP20-CONFIGURED,W/O PACING,ENGLISH
00721902505461LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
00721902505140LP20-CONFIGURED,WITH PACING,ENGLISH
00721902504426LP20-CONFIGURED,W/O PACING,ENGLISH
00721902439681LP20 PACKAGE,PACING,SPO2M,ENGL,DOM
00721902439339LP20 PACKAGE,PACING,ENGL,DOM
00721902438653LP20 PACKAGE,W/OUT PACING,ENGL,DOM
00883873853962Pkg LP20e CMM,AHA USAS,ENG
00883873853863Pkg LP20e CMM,PCNG,AHA USAS,ENG
00883873852804Pkg LP20e CMM,PCNG,SpO2,AHA USAS,ENG
00883873852798Pkg LP20e CMM,PCNG,MNC,SpO2,AHA USAS,ENG

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