GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml 30.9.0290

GUDID 04260341780764

OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent reference for checking the linearity of the instrument in the osmolality range of normal serum.

G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.

Osmolality IVD, calibrator

• Primary Device ID: 04260341780764
• NIH Device Record Key: 469b4059-ab40-481e-881b-3024a2b9d732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml
• Version Model Number: 30.9.0290
• Catalog Number: 30.9.0290
• Company DUNS: 319441788
• Company Name: G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
• Device Count: 10
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com
• Phone: +493078095880
• Email: info@gonotec.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260341780603 [Primary]
GS1	04260341780764 [Unit of Use]

FDA Product Code

• JIS: Calibrator, Primary

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: 2021-05-17
• Device Publish Date: 2021-05-07

Devices Manufactured by G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.

• 04260341780559 - GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O - 10 x 1mL: 2021-05-17 Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.
• 04260341780726 - GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mL: 2021-05-17 Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.
• 04260341780733 - GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL: 2021-05-17 Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.
• 04260341780740 - GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL: 2021-05-17 Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.
• 04260341780757 - GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL: 2021-05-17 Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.
• 04260341780764 - GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml: 2021-05-17OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent reference for checking the linearity of the instrument in the osmolality range of normal serum.
• 04260341780764 - GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml: 2021-05-17 OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent refe