Device
25 Gy Universal Irradiation Tag - Custom Blood Assurance
Manufacturer
TYPENEX MEDICAL LLC
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