ADVIA® Chemistry Electrode CL

Basic Information

• Brand Name: ADVIA® Chemistry Electrode CL
• Primary DI: 00630414482330
• Version / Model: 10309439
• Catalog Number: 073-0049-01
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 5790dd5e-0775-4609-a49e-c0d693ba1d89

Device Description

Chloride - ADVIA Chem. - RGT - 1 Piece

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: 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
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52876	Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of chloride (Cl-) in a clinical specimen, using an ion-selective electrode (ISE) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414482330	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K990346	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius