Demo Flight case

GUDID 03701354404908

Demo Flight case

PLASMABIOTICS

Endoscope clean-storage system
Primary Device ID03701354404908
NIH Device Record Keye578d4da-831d-4a2c-bc27-a97c0cefde9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDemo Flight case
Version Model NumberFCD-Typhoon
Company DUNS262972663
Company NamePLASMABIOTICS
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter
Length71 Centimeter
Width42 Centimeter
Height35 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.9 Inches of Mercury and 1.1 Inches of Mercury

Device Identifiers

Device Issuing AgencyDevice ID
GS103701354404908 [Primary]

FDA Product Code

LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-24
Device Publish Date2021-05-14

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