Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10

Basic Information

• Brand Name: Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10
• Primary DI: 00816068020986
• Version / Model: 3MA003
• Catalog Number: 3MA003
• Company Name: ADVANCED INSTRUMENTS, INC.
• Labeler DUNS: 125006353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: dd1ea2dd-089b-4d6b-9f8c-08793a75659f

Device Description

Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10

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: 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
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	00816068020979	GS1
Primary	00816068020986	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius