Model: MDSCC21E
Catalog: MDSCC21E
DI: 00197344214757
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-15
Current Version: 2026-05-25
Description
CRYOCUBE,ECONOMY,COMBO,UNIT W/SHLDR PAD
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0b9a6035-682e-4d94-b87b-f40dc137c438
Distribution Status:
In Commercial Distribution
DUNS Number:
025460908
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00197344214757
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32965
Name: Circulating-fluid localized thermal therapy system pack, reusable
Definition:
A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.
FDA Product Codes
ILO
Pack, hot or cold, water circulating
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
15
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
90
Item #1 - Storage Handling Type:
Handling Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
90
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
-25
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
70
Item #3 - Storage Handling Type:
Storage Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
4
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
40
Item #4 - Storage Handling Type:
Handling Environment Temperature
Item #5 - Storage Handling Type:
Special Storage Condition, Specify
Item #5 - Storage Handling Special Condition Text:
Handle With Care; Keep Dry; Keep away from sunlight; Protect from freezing, Avoid excessive heat
Item #6 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling Low - @attributes - Value:
80
Item #6 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling High - @attributes - Value:
106
Item #6 - Storage Handling Type:
Handling Environment Atmospheric Pressure