JAS Diagnostics, inc

Basic Information

• Brand Name: JAS Diagnostics, inc
• Primary DI: 00817274022658
• Version / Model: XL-MAG2-40
• Catalog Number: XL-MAG2-40
• Company Name: DREW SCIENTIFIC, INC.
• Labeler DUNS: 144968104
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-15
• Public Version: 1
• Public Version Date: 2018-04-16
• Public Version Status: New
• Public Device Record Key: 9f5100e5-cb95-48a9-9137-6969322f9ea8

Device Description

Magnesium Arsenazo (5 x 40mL)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
JGJ	Photometric Method, Magnesium	Clinical Chemistry	862.1495	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52883	Magnesium (Mg2+) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of magnesium (Mg2+) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274022658	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	20	Liter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Fahrenheit