CareWise

Basic Information

• Brand Name: CareWise
• Primary DI: B939CW5APO1060
• Version / Model: CW4000
• Catalog Number: CW5APO106
• Company Name: SOUTHERN SCIENTIFIC LIMITED
• Labeler DUNS: 289858417
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-16
• Public Version: 1
• Public Version Date: 2023-01-24
• Public Version Status: New
• Public Device Record Key: 681e3fff-92b0-4f91-98b6-23fa357e3bfa

Device Description

C-Trak Apollo Analyser CW4000

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZD	Probe, Uptake, Nuclear	Radiology	892.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38340	Multichannel radiation counting system	A device assembly having multichannel analyser capabilities and designed to detect and quantify radiation emissions and differentially identify unknown radioactive isotopes. Typically a component of imaging or laboratory systems, it has the capability to be adjusted in a manner that allows the user to simultaneously count and differentiate emissions from multiple radioactive isotopes. It incorporates a spectrometer, permanently attached or interchangeable detectors, e.g., probes, a linear amplifier, an adjustable pulse height selector, automated spectral analysis and processing capabilities, a printer, and a display (usually a scalar or count rate meter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B939CW5APO1060	HIBCC

Customer Contacts

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