AMCO AM5070

GUDID 00853258006054

Lithium replacement battery for Philips(TM) Heartstart(TM) FRx Onsite & Home(TM) AED.

Amco International Manufacturing & Design, Inc.

Primary battery

• Primary Device ID: 00853258006054
• NIH Device Record Key: b80779c6-30b6-4cba-aec9-bd8c7805273e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMCO
• Version Model Number: AM5070
• Catalog Number: AM5070
• 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: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853258006054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091548

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

On-Brand Devices [AMCO ]

• 00853258006061: Lithium replacement battery for Philips(TM) Heartstream ForeRunner(TM) AED (BT1)
• 00853258006054: Lithium replacement battery for Philips(TM) Heartstart(TM) FRx Onsite & Home(TM) AED.
• 00853258006047: Lithium replacement battery for Philips(TM) HeartStart(TM) FR2 and FR2+
• 00853258006030: Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390
• 00853258006023: Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) AED G3 9300A,, 9300E shipped
• 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