RadTag

Basic Information

• Brand Name: RadTag
• Primary DI: 07540151300053
• Version / Model: RTX25
• Company Name: Radtag Technologies Inc
• Labeler DUNS: 205610855
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 0ab4858b-bbe3-4cfe-b206-d1ddbd452ce7

Device Description

25/50 Gy Min/Max Blood Irradiation Indicator (X-Ray)

Device Characteristics

• Single Use: Yes
• 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: 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
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64745	Blood irradiation indicator	A label-like device intended to be attached to a blood bag prior to ionizing-radiation (e.g., gamma, X-ray) blood irradiation to verify the type and broad dosage of radiation delivered to the blood. Blood irradiation is a technique designed to inactivate donor lymphocytes and help prevent transfusion-associated graft-versus-host disease. The label is specific to a type of radiation and typically includes a permanent colour-change indicator for dosage, and areas for recording other related data. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540151300053	GS1