LIFEPAK 15 monitor/defibrillator 97577-000106

GUDID 00883873793749

USED DEVICE 97577-000105 LP15 SPO2 EN

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system

• Primary Device ID: 00883873793749
• NIH Device Record Key: 050ed4c4-d39a-4a8d-83d1-7abf490ff3f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFEPAK 15 monitor/defibrillator
• Version Model Number: 97577
• Catalog Number: 97577-000106
• Company DUNS: 009251992
• Company Name: PHYSIO-CONTROL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-1150
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873793749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160026
• Premarket Approval: P160026

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-07
• Device Publish Date: 2018-12-07

On-Brand Devices [LIFEPAK 15 monitor/defibrillator]

• 00883873808245: 15AABAABAABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
• 00883873808238: 15AABAABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
• 00883873808221: 15AABBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
• 00883873808214: 15AACBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
• 00883873808207: 15AACBABBABBBBAAAAAAAAAFLP15 MONITOR/DEFIB
• 00883873808191: 15AAEBABBABBBBAAAAAAAAAFLP15 MONITOR/DEFIB
• 00883873793763: USED DEVICE 97577-000108 LP15 SPO2COM EN
• 00883873793756: USED DEVICE 97577-000104 LP15 SPO2 EN
• 00883873793749: USED DEVICE 97577-000105 LP15 SPO2 EN
• 00883873793732: USED DEVICE 97577-000106 LP15 SPO2CO EN
• 00883873793725: USED DEVICE 97577-000107 LP15 SPO2CO EN
• 00883873793503: USED DEVICE 97577-000109 LP15 SPO2 EN
• 00883873870556: LP15 ACCRY SHIPKIT,AHA
• 00883873870549: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870532: LP15 ACCRY SHIPKIT,AHA,L
• 00883873870525: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870501: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870488: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870464: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870440: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870433: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870419: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870396: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870372: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870358: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870334: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870310: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870303: LP15 ACCRY SHIPKIT,AHA,L
• 00883873870297: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870273: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870266: LP15 ACCRY SHIPKIT,AHA,L
• 00883873870259: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870242: LP15 ACCRY SHIPKIT,AHA,L
• 00883873870235: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870228: LP15 ACCRY SHIPKIT,AHA,L
• 00883873870211: LP15 ACCRY SHIPKIT,AHA,S
• 00883873870198: LP15 ACCRY SHIPKIT,AHA,S
• 00883873762264: USED 15AABBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB/
• 00883873762257: USED 15AACBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB
• 07613327650839: USED LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,IP,TR,VR,V4
• 07613327650792: USED LP15,EN,3L,EX,VR,V4
• 00883873777466: 15AABAAABABBBABAAAAAAABFLP15 MONITOR/DEFIB