Pneupac

GUDID 15019517178845

Smiths Medical International Ltd

Transport electric ventilator
Primary Device ID15019517178845
NIH Device Record Key720a39ac-3119-4ef7-93bb-a98f5dc96c90
Commercial Distribution StatusIn Commercial Distribution
Brand NamePneupac
Version Model Number530A1167NONEU
Company DUNS215590304
Company NameSmiths Medical International Ltd
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
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 465 KiloPascal and 1100 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 465 KiloPascal and 1700 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS115019517178845 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-01-18
Device Publish Date2019-08-01

On-Brand Devices [Pneupac]

35019315107478530A1167
35019315107270P300NUS
35019315107263P310NUS
35019315074862VR1AIRNUS
35019315074183V200DNUS
35019315072738P200DNUS
35019315071892B100NUS
35019315071533APH
35019517160219100/905/340-CH
35019517159602100/905/301-CH
35019517159121100/905/300-CH
45019315079215100/905/361
45019315079208100/905/360
35019315076118100/905/341
35019315076101100/905/340
35019517160226100/905/341-CH
10610586046063122003
10610586046056122002
35019517159664100/905/320-CH
35019517159640100/905/302-CH
15019517178845530A1167NONEU

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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