GE Healthcare Airway Gas Sampling Set 8090121522

GUDID 04251679601524

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

BluePoint Medical GmbH & Co. KG

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• Primary Device ID: 04251679601524
• NIH Device Record Key: ded6da69-69e5-41f8-870e-72bac19aa035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE Healthcare Airway Gas Sampling Set
• Version Model Number: Infant, 2m/7ft
• Catalog Number: 8090121522
• Company DUNS: 507261522
• Company Name: BluePoint Medical GmbH & Co. KG
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 495 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251679601524 [Unit of Use]
GS1	24251679601528 [Primary]
HIBCC	EBPM8090121522 [Secondary]

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [GE Healthcare Airway Gas Sampling Set]

• 04251679601531: Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired resp
• 04251679601524: Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired resp
• 04251679601517: Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired resp