PATIENT CIRCUITS

GUDID 10847946023123

MASK, CPAP, #2, INFANT

Zoll Medical Corporation

Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator
Primary Device ID10847946023123
NIH Device Record Keye6563e74-dfb4-4f9a-a4e9-896a86963edc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePATIENT CIRCUITS
Version Model Number812-0007-20
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 Atmospheric PressureBetween 0 KiloPascal and 0
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Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
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Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
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Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
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Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
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Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
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Device Identifiers

Device Issuing AgencyDevice ID
GS110847946023123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVENTILATOR, CONTINUOUS, FACILITY USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-02-08
Device Publish Date2015-10-28

On-Brand Devices [PATIENT CIRCUITS]

10847946023208CIRCUIT, MRI, VENT, SINGLE LIMB, INFANT
10847946023192CIRCUIT, MRI, VENT, SINGLE LIMB, PED/ADULT
10847946023185CIRCUIT, VENT, SINGLE LIMB, WYE, INFANT
10847946023178CIRCUIT, VENT, SINGLE LIMB, WYE, ADULT/PEDI
10847946023161MASK, CPAP, #6 LARGE ADULT
10847946023154MASK, CPAP, #5 REGULAR ADULT
10847946023147MASK, CPAP, #4, CHILD
10847946023123MASK, CPAP, #2, INFANT
10847946023130MASK, CPAP, #3, SM CHILD
00847946092856PADDED CASE, TAN, ADULT/PEDIATRIC AND INFANT CIRCUITS, BERRY COMPLIANT

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