FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50630140016286
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
11440-512
Catalog number
11440-512
Device description
Cold Pack, Instant, Non-Sweat
Published
2019-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IMDPACK, HOT OR COLD, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50630140016286PackageGS14In Commercial Distribution
20630140016285PrimaryGS10
10630140016288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5063014001628650630140016286
2063014001628520630140016285
1063014001628810630140016288

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA 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, peat) 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
12
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
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00080196732343MEDLINEMEDLINE INDUSTRIES, INC.IMD2026-03-19
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00885914107966Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107973Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107980Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107997Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108000Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108017Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108024Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108031Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108055Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
30665973032611DukalDukal LLCIMD2025-10-31
30665973032628DukalDukal LLCIMD2025-10-31
30860013591930Vpod EliteCool Comforts Co.IMD2025-09-24
40080196733737MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
20888277659664MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
00850056748490FORWARD HEAT - Life GuardINTEGRATED MEDCRAFT LLCIMD2025-09-02
40080196733362MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-08-26
10860010472146Instant Cold Pack 6inx9inMedzah IndustriesIMD2025-08-11
20860012637410Instant Cold Pack 4.75x7Medzah IndustriesIMD2025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inMedzah IndustriesIMD2025-08-11
20860011917483MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
20860012637403MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
00850073571125American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-28
00850073571071American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-09
00840456203828JMUJMU DENTAL, INCIMD2025-06-13
16977244725048HetaidaLinqing HeTaiDa Medical Technology Co., LtdIMD2025-05-12
30860013591909VpodCool Comforts Co.IMD2025-05-02