AutoPulse NXT Resuscitation System 8700-001070

GUDID 00849111003384

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.

Cardiac resuscitator, line-powered
Primary Device ID00849111003384
NIH Device Record Key4aaa1e2f-3693-40c8-89b7-64daade1c1eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoPulse NXT Resuscitation System
Version Model NumberModel 200
Catalog Number8700-001070
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 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100849111003384 [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

On-Brand Devices [AutoPulse NXT Resuscitation System]

00849111003384The AutoPulse NXT System consists of 4 primary components, a reusable Platform, a single use che
00849111003049The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device t
00849111003025Shoulder Restraint English
00849111003018A Battery Charger is a standalone unit intended to charge and test-cycle the Nickel Metal Hydrid

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