Device
25 Gy Universal Irradiation Tag - Custom Blood Assurance
Manufacturer
TYPENEX MEDICAL LLC
Model: RT0301XBA DI: 10810050855843 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-06 Current Version: 2026-05-14
Description
25 Gy Universal Irradiation Tag - Custom Blood Assurance
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 9c145939-a7e4-48db-b713-7160275aeb4a
Distribution Status: In Commercial Distribution
DUNS Number: 600850213
Device Count: 200
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 00810050855846
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10810050855843
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 64745
Name: Blood irradiation indicator
Definition:
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.
FDA Product Codes
IWZ
Film, Radiographic
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 15
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 25
Storage Handling - Storage Handling Type: Storage Environment Temperature