11576-000071

GUDID 00883873881453

LUCAS POWER SUPPLY WITHCORD,REDEL,CANADA,US

Jolife AB

Noninvasive device battery charger

• Primary Device ID: 00883873881453
• NIH Device Record Key: 5a751fc4-7699-4d77-bbb0-c5ccb843e7e7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 11576
• Catalog Number: 11576-000071
• Company DUNS: 632662933
• Company Name: Jolife AB
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873881453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090422

FDA Product Code

• MPD: Auxiliary power supply (AC or DC) for low-energy dc-defibrillator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-04-30

Devices Manufactured by Jolife AB

• 00883873881453 - NA: 2020-02-06LUCAS POWER SUPPLY WITHCORD,REDEL,CANADA,US
• 00883873881453 - NA: 2020-02-06 LUCAS POWER SUPPLY WITHCORD,REDEL,CANADA,US
• 00883873948323 - NA: 2020-02-06 LUCAS BATTERY CHARGER,MAINS PLUG,US-CAN-JA
• 00883873861820 - LUCAS CHEST COMPRESSION SYSTEM: 2018-10-31 LUCAS BATTERY DARK GRAY
• 00883873834329 - LUCAS: 2018-10-05 LUCAS 3, 3.1, IN SHIPPING BOX, EN
• 00883873861875 - LUCAS™ CHEST COMPRESSION SYSTEM: 2018-03-29 LUCAS 3, 3.0, IN SHIPPING BOX, EN
• 00883873904565 - LUCAS™ Chest Compression System: 2018-03-29 LUCAS 2, 2.2, IN SHIPPING BOX,EN
• 00883873948286 - Lucas PCI Back Plate: 2018-03-29 LUCAS PCI BACK PLATE
• 00883873970898 - Lucas Battery Pack: 2018-03-29 LUCAS 2 BATTERY