AutoPulse Charger 8700-0703-03

GUDID 00849111065047

A Battery Charger is a stand alone unit intended to charge and test-cycle the Nickel Metal Hydride Batteries.

Zoll Circulation, Inc.

Noninvasive device battery charger

• Primary Device ID: 00849111065047
• NIH Device Record Key: 04177e7c-6f2c-445a-a081-59e4c4bf6a87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoPulse Charger
• Version Model Number: 100
• Catalog Number: 8700-0703-03
• 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

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111065047 [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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-07-24

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