ROTATING IV POLE

GUDID 00840682143691

ROTATING IV POLE

DATEX-OHMEDA INC

Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole Freestanding/bed-attached intravenous pole
Primary Device ID00840682143691
NIH Device Record Keyf4f7d0be-487b-4ec1-854d-1ffbdb8d92a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameROTATING IV POLE
Version Model NumberRotating IV1
Company DUNS080887689
Company NameDATEX-OHMEDA INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682143691 [Primary]

FDA Product Code

FOXStand, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

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00840682143684 - IV POLE ASSY 12 IN2022-12-14 IV POLE 12 IN
00840682143691 - ROTATING IV POLE2022-12-14ROTATING IV POLE
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00840682143707 - IV POLE ASSY 24 IN2022-12-14 IV POLE 24 IN
00195278579157 - ET CONTROL OPTION2022-07-29 ET CONTROL OPTION

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