AutoPulse NXT Multi-Chemistry Battery Charger 8700-001071

GUDID 00849111003568

The AutoPulse NXT 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.

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Primary Device ID00849111003568
NIH Device Record Keye3fa2485-a5fc-4253-b9b8-ce489b8d6608
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoPulse NXT Multi-Chemistry Battery Charger
Version Model NumberModel 200
Catalog Number8700-001071
Company DUNS799455241
Company NameZoll Circulation, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100849111003568 [Primary]

FDA Product Code

DRMCompressor, Cardiac, External

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-23
Device Publish Date2023-10-13

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00849111002998 - AutoPulse Li-ion Battery2023-10-25 Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform System.
00849111003032 - AutoPulse NXT2023-10-25 AutoPulse NXT Quick Case.
10849111002988 - LifeBand® Load-distributing Band2023-10-25 Single-use chest compression band. (3 per package)
00849111002981 - LifeBand® Load-distributing Band2023-10-24 Single-use chest compression band.
00849111003018 - AutoPulse NXT Resuscitation System2023-10-23 A Battery Charger is a standalone unit intended to charge and test-cycle the Nickel Metal Hydride Batteries.
00849111003025 - AutoPulse NXT Resuscitation System2023-10-23 Shoulder Restraint English

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