LIFEPAK 15 monitor/defibrillator 97577-000102

GUDID 00883873808207

15AACBABBABBBBAAAAAAAAAFLP15 MONITOR/DEFIB

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system
Primary Device ID00883873808207
NIH Device Record Keycebeed32-eca8-4a0a-8a45-6589c6290def
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFEPAK 15 monitor/defibrillator
Version Model Number97577
Catalog Number97577-000102
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)442-1146
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

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended storage temperature is -20 to 65 celsius (-4 to 140 Fahrenheit) except therapy electrodes and batteries.
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended storage temperature is -20 to 65 celsius (-4 to 140 Fahrenheit) except therapy electrodes and batteries.
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended storage temperature is -20 to 65 celsius (-4 to 140 Fahrenheit) except therapy electrodes and batteries.
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873808207 [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 Date2019-01-07
Device Publish Date2018-12-07

On-Brand Devices [LIFEPAK 15 monitor/defibrillator]

0088387380824515AABAABAABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
0088387380823815AABAABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
0088387380822115AABBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
0088387380821415AACBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
0088387380820715AACBABBABBBBAAAAAAAAAFLP15 MONITOR/DEFIB
0088387380819115AAEBABBABBBBAAAAAAAAAFLP15 MONITOR/DEFIB
00883873793763USED DEVICE 97577-000108 LP15 SPO2COM EN
00883873793756USED DEVICE 97577-000104 LP15 SPO2 EN
00883873793749USED DEVICE 97577-000105 LP15 SPO2 EN
00883873793732USED DEVICE 97577-000106 LP15 SPO2CO EN
00883873793725USED DEVICE 97577-000107 LP15 SPO2CO EN
00883873793503USED DEVICE 97577-000109 LP15 SPO2 EN
00883873870556LP15 ACCRY SHIPKIT,AHA
00883873870549LP15 ACCRY SHIPKIT,AHA,S
00883873870532LP15 ACCRY SHIPKIT,AHA,L
00883873870525LP15 ACCRY SHIPKIT,AHA,S
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00883873870488LP15 ACCRY SHIPKIT,AHA,S
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00883873870310LP15 ACCRY SHIPKIT,AHA,S
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00883873870266LP15 ACCRY SHIPKIT,AHA,L
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00883873870242LP15 ACCRY SHIPKIT,AHA,L
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00883873870228LP15 ACCRY SHIPKIT,AHA,L
00883873870211LP15 ACCRY SHIPKIT,AHA,S
00883873870198LP15 ACCRY SHIPKIT,AHA,S
00883873762264USED 15AABBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB/
00883873762257USED 15AACBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB
07613327650839USED LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,IP,TR,VR,V4
07613327650792USED LP15,EN,3L,EX,VR,V4
0088387377746615AABAAABABBBABAAAAAAABFLP15 MONITOR/DEFIB
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