Device
Portable refrigeration unit for temperature-sensitive, vital supplies (i.e. blood).
Manufacturer
TACTICAL MEDICAL SOLUTIONS, LLC
TACTICAL MEDICAL SOLUTIONS, LLC
Model: A
Catalog: 104126
DI: 00818630019053
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Portable refrigeration unit for temperature-sensitive, vital supplies (i.e. blood).
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3e2d6ad6-e710-4c5a-b6f1-bcad9708bcd3
Distribution Status:
In Commercial Distribution
DUNS Number:
131480662
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00818630019053
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35486
Name: Blood refrigerator
Definition:
An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).
FDA Product Codes
KSE
Refrigerator, Freezer, Blood Storage