Secure Dosimetry Bundle

Basic Information

• Brand Name: Secure Dosimetry Bundle
• Primary DI: 00860010101223
• Version / Model: RSD-BD
• Company Name: Rampart Ic, LLC
• Labeler DUNS: 117119538
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-08
• Public Version: 1
• Public Version Date: 2025-08-18
• Public Version Status: New
• Public Device Record Key: c6030483-1fd1-4c56-af6c-d6a3c50da280

Device Description

Badge Dosimeters

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
38350	Film-badge radiation dosimeter	A non-sterile device designed to record the integrated gamma-ray, x-ray, beta particles or Bremsstrahlung dose to an individual, usually a healthcare provider, using photographic or x-ray film and filters to discriminate energy absorption characteristics, a reusable holder containing the film/filters, and a means of attaching the holder to the person. Chemical changes in the silver halide crystals in the film that result from exposure to radiation are recorded during film processing as black crystals. The radiation induced optical density in the film is proportional to the radiation exposure. It may be worn in a variety of locations to record whole-body, eye, extremity or finger exposures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010101223	GS1