FDA.reportPublic FDA data

MEDLINE

Primary DI
00197344214757
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDSCC21E
Catalog number
MDSCC21E
Device description
CRYOCUBE,ECONOMY,COMBO,UNIT W/SHLDR PAD
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, hot or cold, water circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197344214757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344214757001973442147571973442147570197344214757

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system pack, reusableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature4 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Handle With Care; Keep Dry; Keep away from sunlight; Protect from freezing, Avoid excessive heat
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24
30193489017759MEDLINE6651CBL22X26651CBL22X22026-07-24
30193489017766MEDLINE6651CBL22X36651CBL22X32026-07-24
30193489017773MEDLINE6651CBL22X46651CBL22X42026-07-24
30193489017780MEDLINE6651CBL34X36651CBL34X32026-07-24
30193489017797MEDLINE6651CBL34X46651CBL34X42026-07-24
30193489104893MEDLINEMDT011201XLMDT011201XL2026-07-24
40193489107969MEDLINEMDTISO3AHCAR3MDTISO3AHCAR32026-07-24
40193489120241MEDLINEMDTISO3AHGMDTISO3AHG2026-07-24
40193489120258MEDLINEMDTISO3AHG3XLMDTISO3AHG3XL2026-07-24
50080196247576MEDLINEMDT011205MDT0112052026-07-24
50193489109885MEDLINEMDTISO3AHY3XLMDTISO3AHY3XL2026-07-24
50193489109892MEDLINEMDTISO3AHYCARMDTISO3AHYCAR2026-07-24
10193489987522MEDLINEURO175814TURO175814T2022-05-22
10193489987546MEDLINEURO175818TURO175818T2022-05-22
10193489988505MEDLINEURO175816TURO175816T2022-05-22
00080196311661MEDLINENON241278NON2412782026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
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06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880871CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-19
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641888518CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2025-09-16
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10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
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