ComfortLite

Basic Information

• Brand Name: ComfortLite
• Primary DI: 00840348528510
• Version / Model: LP-C800X
• Catalog Number: LP-C800X
• Company Name: AADCO MEDICAL, INC.
• Labeler DUNS: 153603204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 1
• Public Version Date: 2022-12-21
• Public Version Status: New
• Public Device Record Key: d6492d52-24a7-4216-a462-afaa9d9ce95c

Device Description

COMFORTLITE THYROID PATTERN

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
EAJ	Apron, Leaded	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38358	Radiation shielding collar	A personal protective device intended to shield the neck area including the nape, the throat, and the thyroid of an individual (i.e., a device operator or other attending person) from unnecessary exposure to radiation during diagnostic or therapeutic medical and dental procedures. Collars used in x-ray and nuclear medicine typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Collars used for neutron attenuation are composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840348528510	GS1