GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL

Basic Information

• Brand Name: GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL
• Primary DI: 04260341780580
• Version / Model: 30.9.0850
• Catalog Number: 30.9.0850
• Company Name: G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
• Labeler DUNS: 319441788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-05-07
• Public Version: 1
• Public Version Date: 2021-05-17
• Public Version Status: New
• Public Device Record Key: 85f4721f-5b64-4aa7-a7d2-6cf14d9c08c2

Device Description

Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIS	Calibrator, Primary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52885	Osmolality IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04260341780740	GS1
Primary	04260341780580	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius