AED Battery Exchange

GUDID 00864312000284

Lithium sulfur dioxide battery for use with Cardiac Science(TM) G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C

AED BATTERY EXCHANGE, LLC

Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack Disposable battery pack

• Primary Device ID: 00864312000284
• NIH Device Record Key: 840a07bd-bd42-4c05-b0a6-d1046c777203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED Battery Exchange
• Version Model Number: G5-ABE
• Company DUNS: 039840984
• Company Name: AED BATTERY EXCHANGE, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864312000284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190013

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: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [AED Battery Exchange]

• 00864312000260: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 9200RD, 9
• 00864312000253: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,
• 00864312000246: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,
• 00864312000239: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,
• 00864312000222: Lithium - Sulfur Dioxide battery for replacement in Lifepak 500(TM) AED.
• 00864312000215: Lithium Manganese Dioxide battery for replacement in Philips(TM) HeartStart(TM) FR2 and FR2+
• 00864312000208: Lithium Manganese Dioxide battery for replacement in Philips(TM) Heartstart(TM) FRx Onsite & Hom
• 00864312000284: Lithium sulfur dioxide battery for use with Cardiac Science(TM) G5 models G5A-80A, G5A-80C, G5S-
• 00864312000277: Lithium Manganese Dioxide battery for use in Philips(TM) HeartStart(TM) FR3 AED's 861388 and 861