GE Healthcare Airway Adapter 3090121002

GUDID 04251679601548

Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.

BluePoint Medical GmbH & Co. KG

Gas-sampling/monitoring respiratory tubing, single-use
Primary Device ID04251679601548
NIH Device Record Key59af90d4-92be-4891-9d2f-b6ca08f7390b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGE Healthcare Airway Adapter
Version Model NumberAdult/Pediatric
Catalog Number3090121002
Company DUNS507261522
Company NameBluePoint Medical GmbH & Co. KG
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 495 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104251679601548 [Unit of Use]
GS124251679601542 [Primary]
HIBCCEBPM3090121002 [Secondary]

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-28
Device Publish Date2020-02-20

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04251679601517 - GE Healthcare Airway Gas Sampling Set2020-02-28 Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
04251679601524 - GE Healthcare Airway Gas Sampling Set2020-02-28 Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
04251679601531 - GE Healthcare Airway Gas Sampling Set2020-02-28 Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
04251679601548 - GE Healthcare Airway Adapter2020-02-28Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
04251679601548 - GE Healthcare Airway Adapter2020-02-28 Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.

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