Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U

GUDID 03701354405103

Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U

PLASMABIOTICS

Endoscope clean-storage system
Primary Device ID03701354405103
NIH Device Record Keyb4b1a4c2-6d32-4247-b8fd-62703cff4bb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U
Version Model NumberPP EEB-J10
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

Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 Centimeter
Length34 Centimeter
Width23 Centimeter
Height3 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
GS103701354405103 [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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03701354405103 - Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U2021-05-24Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U
03701354405103 - Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U2021-05-24 Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U

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