Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500

Basic Information

• Brand Name: Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500
• Primary DI: 10816068020600
• Version / Model: 200223
• Catalog Number: 200223
• Company Name: ADVANCED INSTRUMENTS, INC.
• Labeler DUNS: 125006353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 1
• Public Version Date: 2020-09-29
• Public Version Status: New
• Public Device Record Key: 81ee33ce-6c24-40f5-bfc9-aea20ad3011f

Device Description

Sample tubes for use with the A2O Advanced Automated Osmometer

Device Characteristics

• Single Use: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJM	Osmometer For Clinical Use	Clinical Chemistry	862.2730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52884	Osmolality IVD, kit, freezing point	A collection of reagents and other associated materials intended to be used for the quantitative measurement of osmolality of a clinical specimen, using a freezing point method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816068020603	GS1
Primary	10816068020600	GS1

Customer Contacts

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