FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
40888499002853
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
70304R
Catalog number
70304R
Device description
Hot/Cold Pack
Published
2018-05-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMEPack, hot or cold, reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888499002853PackageGS112Not in Commercial Distribution
00888499002855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4088849900285340888499002853
00888499002855008884990028558884990028550888499002855

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998026140Solventum™Solventum US LLCIME2026-02-15
00197998026171Solventum™Solventum US LLCIME2026-02-15
00197998026621Solventum™Solventum US LLCIME2026-02-15
00197998320255Solventum™Solventum US LLCIME2026-02-15
00810178881840Arctic FlexVIVE HEALTH LLCIME2026-02-05
00818323024869Arctic FlexVIVE HEALTH LLCIME2026-02-03
00885914107898Sammons PrestonPerformance Health Supply, LLCIME2026-01-23
06973641884206CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884213CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884220CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884237CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884244CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884251CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884268CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884275CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884282CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884299CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884305CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884312CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884329CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884336CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884343CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884350CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884367CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884374CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884381CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884398CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884404CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884411CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884428CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22