IRRADIATION INDICATOR TAG

Basic Information

• Brand Name: IRRADIATION INDICATOR TAG
• Primary DI: 00810050854870
• Version / Model: RT0201XLB
• Company Name: TYPENEX MEDICAL LLC
• Labeler DUNS: 600850213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-22
• Public Version: 1
• Public Version Date: 2022-08-30
• Public Version Status: New
• Public Device Record Key: 66e3ebaf-6c1c-4c39-8d4f-af0e894f92b5

Device Description

25 GY IRRADIATION INDICATOR TAG - XRAY CUSTOM IMPACT LIFE

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: No
• Has Manufacturing Date: No
• 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
IWZ	Film, Radiographic	Radiology	892.1840	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
Package	00810050854887	GS1	Case	200	In Commercial Distribution
Primary	00810050854870	GS1
Package	10810050854884	GS1	Shipper	25	In Commercial Distribution