Captus 4000e Thyroid Uptake System with 2 in well

Basic Information

• Brand Name: Captus 4000e Thyroid Uptake System with 2 in well
• Primary DI: 00859942006423
• Version / Model: 5430-30154
• Catalog Number: 5430-30154
• Company Name: Mirion Technologies (capintec), Inc.
• Labeler DUNS: 047684501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-11
• Public Version: 2
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: 3b7269e5-3e02-4e1c-8cca-f6330b490d6c

Device Description

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
40648	Thyroid-uptake nuclear medicine system	An assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It can typically be upgraded with the addition of software and hardware for use in various quality assurance (QA) or radioimmunoassay laboratory applications, e.g., wipe-test assessment or Schilling tests. It typically includes a multichannel analyser, computer, scintillation detector, detector support equipment, an operator's console, video display, well counter detector, collimator, shielding, and application software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859942006423	GS1

Customer Contacts

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