LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 70507-000055

GUDID 00885074515359

LP20E PACKAGE,PACING,ENGL,DOM

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system
Primary Device ID00885074515359
NIH Device Record Keyfd82e1d5-fc92-4c48-b4a8-2e7be8da1127
Commercial Distribution Discontinuation2019-05-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors
Version Model Number70507
Catalog Number70507-000055
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.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

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage at extreme temperatures of -20 to 60 C (-4 or 140 F) 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
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
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 C (-4 or 140 F) 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
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
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 C (-4 or 140 F) 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
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873813683 [Primary]
GS100885074515359 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-09
Device Publish Date2014-11-05

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

00885074856179LP20 - CONFIGD,AHA 2005,PACING,SPO2,ENG
00885074856148LP20 - CONFIGURED, AHA 2005, PACING, ENGLISH
00885074856131LP20 - CONFIGURED, AHA 2005, ENGLISH
00885074854526LP20E-CONFIGURED, AHA 2005, PACE, MNC SPO2, ENG
00885074852133LP20E PACKAGE - CMM, PACING, SPO2, ENGLISH
00885074851921LP20E PACKAGE - CMM,PCNG,MNC SPO2, ENGLISH
00885074851877LP20E PACKAGE - CMM, PACING, ENGLISH
00885074851327LP20E PACKAGE - CMM, ENGLISH
00885074790060LP20 - CONFIGURED, AHA 2005, ENGLISH
00885074790053LP20 - CONFIGURED, AHA 2005, PACING, ENGLISH
00885074789057LP20 PACKAGE - AHA 2005,PACING, ENGLISH
00885074789040LP20 PACKAGE - AHA 2005,PACING,SPO2,ENGLISH
00885074789033LP20 - CONFIGD,AHA 2005,PACING,SPO2,ENG
00885074788999LP20 PACKAGE - AHA 2005,ENGLISH
00885074515359LP20E PACKAGE,PACING,ENGL,DOM
00885074515281LP20E-CONFIGURED, AHA 2005,PCNG, SPO2,ENGLISH
00885074515267LP20E - CONFIGURED, AHA2005 PACING, LI-ION, EN
00885074515250LP20E - CONFIGURED,AHA 2005, LI-ION, ENGLISH
00885074512617LP20 PACKAGE,PACING,SPO2 M, LI-ION,ENGL,DOM
00885074494371LP20 PACKAGE,LI-ION,DOMENGL
00883873887806LP20E CONFIGURED - CMM,ENGLISH
00883873887790LP20E CONFIGURED - CMM,PACING, ENGLISH
00883873887707LP20E CONFIGURED - CMM,PACING, SPO2,ENGLISH
00883873887660LP20E CONFIGURED - CMM,PACING, MNC SPO2, ENG

Trademark Results [LIFEPAK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIFEPAK
LIFEPAK
86865167 not registered Live/Pending
Physio-Control, Inc.
2016-01-04
LIFEPAK
LIFEPAK
75369940 not registered Dead/Abandoned
Voice of The Martyrs, Inc., The
1997-10-08
LIFEPAK
LIFEPAK
74419560 1935867 Live/Registered
NSE PRODUCTS, INC.
1993-07-27
LIFEPAK
LIFEPAK
73615958 1445015 Live/Registered
PHYSIO-CONTROL CORPORATION
1986-08-21
LIFEPAK
LIFEPAK
73340281 1214742 Live/Registered
Physio-Control Corporation
1981-12-07
LIFEPAK
LIFEPAK
72395059 0953669 Dead/Expired
WEBSTER LIFE INSURANCE COMPANY
1971-06-16
LIFEPAK
LIFEPAK
72390299 0935766 Live/Registered
PHYSIO-CONTROL CORPORATION
1971-04-26

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