Phoenix Diagnostics

Basic Information

• Brand Name: Phoenix Diagnostics
• Primary DI: 00853366007288
• Version / Model: 16-218
• Catalog Number: 16-218
• Company Name: PHOENIX DIAGNOSTICS, INC.
• Labeler DUNS: 606814960
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-26
• Public Version: 4
• Public Version Date: 2020-03-30
• Public Version Status: Update
• Public Device Record Key: 652f67f5-9519-4243-86d7-19981af8f526

Device Description

K Calibrator for Roche / Hitachi Chemistry 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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52893	Potassium (K+) 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 potassium (K+) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853366007288	GS1
Package	10853366007285	GS1		10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013451	000

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius