LISO2,FAA,LITHIUM BATTERY 11141-000014

GUDID 00681490576345

ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA

PHYSIO-CONTROL, INC.

Primary battery

• Primary Device ID: 00681490576345
• NIH Device Record Key: 8ad4e329-faa4-4780-885d-11e48c584814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LISO2,FAA,LITHIUM BATTERY
• Version Model Number: 11141
• Catalog Number: 11141-000014
• 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)442-1142
• 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

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490576345 [Primary]
GS1	00883873796153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052057

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: 2019-04-23
• Device Publish Date: 2019-04-15

On-Brand Devices [LISO2,FAA,LITHIUM BATTERY]

• 00681490576345: ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA
• 00883873981641: KIT-LISO2,FAA,LITHIUM BATTERY REPLACEMENT ASSY