AutoPulse® Resuscitation System 8700-0700-01

GUDID 00849111000017

The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger.

Zoll Circulation, Inc.

Cardiac resuscitator, line-powered

• Primary Device ID: 00849111000017
• NIH Device Record Key: 8e3636a8-c49b-4ab0-abf3-ece20cc85a4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoPulse® Resuscitation System
• Version Model Number: 100
• Catalog Number: 8700-0700-01
• 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 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111000017 [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

Devices Manufactured by Zoll Circulation, Inc.

• 00849111075787 - Thermogard XP, Lang set C, Rohs: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle
• 00849111075794 - Thermogard XP, Lang set C, Rohs, Refurb: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle
• 00849111002998 - AutoPulse Li-ion Battery: 2023-10-25 Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform System.
• 00849111003032 - AutoPulse NXT: 2023-10-25 AutoPulse NXT Quick Case.
• 10849111002988 - LifeBand® Load-distributing Band: 2023-10-25 Single-use chest compression band. (3 per package)
• 00849111002981 - LifeBand® Load-distributing Band: 2023-10-24 Single-use chest compression band.
• 00849111003018 - AutoPulse NXT Resuscitation System: 2023-10-23 A Battery Charger is a standalone unit intended to charge and test-cycle the Nickel Metal Hydride Batteries.
• 00849111003025 - AutoPulse NXT Resuscitation System: 2023-10-23 Shoulder Restraint English