Capre F5 AM Capre F5 AM

GUDID 06430021930538

Treatment table

Lojer Oy

Examination/treatment table, line-powered

• Primary Device ID: 06430021930538
• NIH Device Record Key: 297a18f1-562d-4e1d-97fc-9e1e4de101a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capre F5 AM
• Version Model Number: Capre F5 AM
• Catalog Number: Capre F5 AM
• Company DUNS: 368184922
• Company Name: Lojer Oy
• 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

Customer Support Contacts

• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com
• Phone: +358108306700
• Email: info@lojer.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature - 10 to +40 °C

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430021930538 [Primary]

FDA Product Code

• INQ: Table, Powered

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: 2022-12-08
• Device Publish Date: 2022-11-30

Devices Manufactured by Lojer Oy

• 06430021930453 - Capre M2: 2022-12-08 Treatment table
• 06430021930460 - Capre M4: 2022-12-08 Treatment table
• 06430021930477 - Capre M4 AM: 2022-12-08 Treatment table
• 06430021930507 - Capre F2: 2022-12-08 Treatment table
• 06430021930514 - Capre F3: 2022-12-08 Treatment table
• 06430021930521 - Capre F5: 2022-12-08 Treatment table
• 06430021930538 - Capre F5 AM: 2022-12-08Treatment table
• 06430021930538 - Capre F5 AM: 2022-12-08 Treatment table
• 06430021930569 - Capre FX3: 2022-12-08 Treatment table