FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20192253061427
Brand
CARDINAL HEALTH
Company
CARDINAL HEALTH 200, LLC
Model
11460-010T
Catalog number
11460-010T
Device description
Cardinal Health Infant Heel Warmer Infant Heel Instant Squeeze Activation
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MPOInfant heel warmer (chemical heat pack)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPOInfant Heel Warmer (Chemical Heat Pack)Physical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253061427PackageGS125In Commercial Distribution
50192253061428PackageGS14In Commercial Distribution
10192253061420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225306142720192253061427
5019225306142850192253061428
1019225306142010192253061420

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Width4Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
112164780
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00885914108048Sammons PrestonPerformance Health Supply, LLCMPO2026-01-23
40080196749967MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-10-21
20860011917490MEDZAH INFANT HEEL WARMERMedzah IndustriesMPO2025-07-30
10850061859225GCB Medical SupplyGCB MEDICAL LLCMPO2025-07-29
40080196719656MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-07-01
20885632413831HalyardOWENS & MINOR DISTRIBUTION, INC.MPO2024-03-04
30885632413807HalyardOWENS & MINOR DISTRIBUTION, INC.MPO2024-03-01
20888277400297MedlineMEDLINE INDUSTRIES, INC.MPO2023-10-13
00850018561594Infant Heel WarmerINTERNATIONAL BIOMEDICAL, LTD.MPO2023-06-20
00850018561600Infant Heel SnugglerINTERNATIONAL BIOMEDICAL, LTD.MPO2023-06-20
20885380193214CARDINAL HEALTHCARDINAL HEALTH 200, LLCMPO2023-06-19
20192253061465NOVAPLUSCardinal Health 200, LLCMPO2023-02-27
20192253061434CARDINAL HEALTHCardinal Health 200, LLCMPO2023-02-21
30888937025690Cooper Surgical INFANT HEEL WARMERCoopersurgical, Inc.MPO2022-11-29
20888937025716WARMGEL INFANT HEEL WARMERCoopersurgical, Inc.MPO2022-11-29
00850046230097Future Generation Medical Global International L. L. C.MPO2022-11-13
00850046230103Future Generation Medical Global International L. L. C.MPO2022-11-13
00860008614605AtlanticMEDAtlantic Trading LLCMPO2022-11-09
00840216119291ASP MEDICALAsp Global, LLCMPO2022-08-15
00840216119505ASP MEDICALAsp Global, LLCMPO2022-08-15
30885632366264MediChoiceOWENS & MINOR DISTRIBUTION, INC.MPO2022-05-13
50749756312924DeRoyalDEROYAL INDUSTRIES, INC.MPO2021-07-09
30885632057759MediChoiceOWENS & MINOR DISTRIBUTION, INC.MPO2020-09-30
10818566017618PremierProSVS LLCMPO2020-08-04
20612479153435McKessonMCKESSON MEDICAL-SURGICAL INC.MPO2020-07-20
20612479191208McKessonMCKESSON MEDICAL-SURGICAL INC.MPO2020-03-31
10849027001808HCSDYAD MEDICAL SOURCING, LLCMPO2019-12-31
50885380073852CARDINAL HEALTHCardinal Health 200, LLCMPO2019-05-30
20630140017398CARDINAL HEALTHCARDINAL HEALTH 200, LLCMPO2018-12-28
00817517020205Marketlab IncMARKETLAB INC.MPO2018-11-16