Precision Systems 300 mOsm Osmometry Standard

Basic Information

• Brand Name: Precision Systems 300 mOsm Osmometry Standard
• Primary DI: 00850041049038
• Version / Model: 2103
• Catalog Number: 2103
• Company Name: Precision Systems, Inc.
• Labeler DUNS: 001001676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-14
• Public Version: 1
• Public Version Date: 2023-10-23
• Public Version Status: New
• Public Device Record Key: ff415a2a-f752-48d0-bc05-b05841e70f86

Device Description

Precision Systems 300 mOsm Osmometry Standard, 125 mL bottle

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
JMZ	Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality	Clinical Chemistry	862.1540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52886	Osmolality IVD, control	A material which is used to verify the performance of 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
Primary	00850041049038	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius