Alfa Wassermann

Basic Information

• Brand Name: Alfa Wassermann
• Primary DI: 00857969006037
• Version / Model: 903393
• Catalog Number: 903393
• Company Name: ALFA WASSERMANN, INC.
• Labeler DUNS: 781990924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 67516618-482b-4ac2-bff0-32914c6cde19

Device Description

Electrode, Sodium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59249	Sodium (Na+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857969006037	GS1

Customer Contacts

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