Pneupac

GUDID 15019517180381

Smiths Medical ASD, Inc.

Transport electric ventilator
Primary Device ID15019517180381
NIH Device Record Key0de44427-c764-453e-a19e-55d6e91e50dc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePneupac
Version Model Number530A1167NFRNONEU
Company DUNS082005361
Company NameSmiths Medical ASD, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS115019517180381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, emergency, powered (resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-07
Device Publish Date2019-05-30

On-Brand Devices [Pneupac]

15019517181173510A1960NONEU
15019517180367530A1166NONEU
15019517189513520A1125NONEU
15019517180381530A1167NFRNONEU
15019517180374530A1166NFRNONEU

Trademark Results [Pneupac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PNEUPAC
PNEUPAC
75758396 2345686 Live/Registered
SMITHS MEDICAL INTERNATIONAL LIMITED
1999-07-23
PNEUPAC
PNEUPAC
73372613 1295889 Dead/Cancelled
Pneupac Limited
1982-07-01

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