RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor

Basic Information

• Brand Name: RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor
• Primary DI: 00630414452289
• Version / Model: 10309082
• Catalog Number: 4955798
• 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: 2021-11-19
• Public Version Status: Update
• Public Device Record Key: 38d0d833-bcd6-4d37-97df-87b40e705415

Device Description

RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems.

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
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59248	Potassium (K+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414452289	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K000926	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius