AED Battery Exchange

GUDID 00864312000215

Lithium Manganese Dioxide battery for replacement in Philips(TM) HeartStart(TM) FR2 and FR2+

AED BATTERY EXCHANGE, LLC

Primary battery

• Primary Device ID: 00864312000215
• NIH Device Record Key: ccd401bc-acbc-4c8c-8f77-51bd528c572c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED Battery Exchange
• Version Model Number: 3863-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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864312000215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120350

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: 2016-03-08

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