AutoPulse Li-ion Battery™ 8700-0752-04

GUDID 00849111002660

Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform.

Zoll Circulation, Inc.

Secondary battery

• Primary Device ID: 00849111002660
• NIH Device Record Key: c32a8141-6eac-4f5c-86dc-30a0a7ba089f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoPulse Li-ion Battery™
• Version Model Number: 100
• Catalog Number: 8700-0752-04
• Company DUNS: 799455241
• Company Name: Zoll Circulation, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4085412140
• Email: udisj@zoll.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111002660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112998

FDA Product Code

• DRM: Compressor, Cardiac, External

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: 2015-07-24

On-Brand Devices [AutoPulse Li-ion Battery™]

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• 00849111001830: Original equipment Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform.
• 00849111001823: Box containing Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform.