AMCO 5L500

GUDID 00853258006009

Lithium replacement battery for Physio-Control LifePak 500(TM) AED

Amco International Manufacturing & Design, Inc.

Primary battery

• Primary Device ID: 00853258006009
• NIH Device Record Key: 3d72eda5-0f4e-41a5-9afc-4db0e9254fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMCO
• Version Model Number: 5L500
• Catalog Number: 5L500
• Company DUNS: 830424854
• Company Name: Amco International Manufacturing & Design, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com
• Phone: 7183888668
• Email: amco@amcomfginc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853258006009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072596

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)
• MOY: Batteries, Rechargeable, For Class 3 Devices

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-14

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• 00853258006016: Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD, and Survival
• 00853258006009: Lithium replacement battery for Physio-Control LifePak 500(TM) AED