ResQGARD MP KIT

GUDID 00847946045326

RESQGARD MP KIT

Zoll Medical Corporation

Demand valve
Primary Device ID00847946045326
NIH Device Record Key2ac8e55a-8add-4f64-ba94-78dc53200432
Commercial Distribution StatusIn Commercial Distribution
Brand NameResQGARD MP KIT
Version Model Number12-2387-030
Company DUNS055363428
Company NameZoll Medical Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946045326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-19
Device Publish Date2021-07-09

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00198843000117 - ZENIX2025-10-01 ZENIX, EMS BLS CONFIGURATION
00198843000131 - ZENIX2025-10-01 ZENIX, EMS BLS + VENTILATION CONFIGURATION
00198843000063 - ZENIX2025-09-29 ZENIX, EMS STANDARD CONFIGURATION
00198843000087 - ZENIX2025-09-29 ZENIX, EMS CRITICAL CARE CONFIGURATION
00198843000100 - ZENIX2025-09-29 ZENIX, EMS FIRE CONFIGURATION

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