PROGNOST XS 7034-0-0000

GUDID 04260502640357

Basic diagnostic x-ray system table, non-powered

PROTEC GmbH & Co. KG

Basic diagnostic x-ray system table, non-powered

• Primary Device ID: 04260502640357
• NIH Device Record Key: 6ca81dfa-eed5-4b2d-84bf-d5fcf6a6d51b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROGNOST XS
• Version Model Number: table top 196,3x65,5cm composite fiber
• Catalog Number: 7034-0-0000
• Company DUNS: 314629130
• Company Name: PROTEC GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260502640043 [Previous]
GS1	04260502640357 [Primary]

FDA Product Code

• KXJ: Table, Radiologic

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: 2020-12-23
• Device Publish Date: 2020-12-15

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