FDA.reportPublic FDA data

NOVAPLUS

Primary DI
10192253061468
Brand
NOVAPLUS
Company
Cardinal Health 200, LLC
Model
V11460-010
Catalog number
V11460-010
Device description
NovaPlus Infant Heel Warmer
Published
2023-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20192253061465PackageGS125In Commercial Distribution
50192253061466PackageGS14In Commercial Distribution
10192253061468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225306146520192253061465
5019225306146650192253061466
1019225306146810192253061468

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, single-useA non-powered 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, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Width4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885914108048Sammons PrestonPerformance Health Supply, LLCMPO2026-01-23
00080196749969MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-10-21
40080196749967MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-10-21
10860011917493MEDZAH INFANT HEEL WARMERMedzah IndustriesMPO2025-07-30
20860011917490MEDZAH INFANT HEEL WARMERMedzah IndustriesMPO2025-07-30
00850061859228GCB Medical SupplyGCB MEDICAL LLCMPO2025-07-29
10850061859225GCB Medical SupplyGCB MEDICAL LLCMPO2025-07-29
10080196719655MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-07-01
40080196719656MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-07-01
10885632413834HalyardOWENS & MINOR DISTRIBUTION, INC.MPO2024-03-04
20885632413831HalyardOWENS & MINOR DISTRIBUTION, INC.MPO2024-03-04
10885632413803HalyardOWENS & MINOR DISTRIBUTION, INC.MPO2024-03-01
30885632413807HalyardOWENS & MINOR DISTRIBUTION, INC.MPO2024-03-01
10888277400290MedlineMEDLINE INDUSTRIES, INC.MPO2023-10-13
20888277400297MedlineMEDLINE INDUSTRIES, INC.MPO2023-10-13
00850018561594Infant Heel WarmerINTERNATIONAL BIOMEDICAL, LTD.MPO2023-06-20
00850018561600Infant Heel SnugglerINTERNATIONAL BIOMEDICAL, LTD.MPO2023-06-20
10885380193217CARDINAL HEALTHCardinal Health 200, LLCMPO2023-06-19
20885380193214CARDINAL HEALTHCARDINAL HEALTH 200, LLCMPO2023-06-19
20192253061465NOVAPLUSCardinal Health 200, LLCMPO2023-02-27
10192253061420CARDINAL HEALTHCardinal Health 200, LLCMPO2023-02-21
10192253061437CARDINAL HEALTHCardinal Health 200, LLCMPO2023-02-21
20192253061427CARDINAL HEALTHCARDINAL HEALTH 200, LLCMPO2023-02-21
20192253061434CARDINAL HEALTHCardinal Health 200, LLCMPO2023-02-21
20888937025693Cooper Surgical INFANT HEEL WARMERCoopersurgical, Inc.MPO2022-11-29
30888937025690Cooper Surgical INFANT HEEL WARMERCoopersurgical, Inc.MPO2022-11-29
20888937025716WARMGEL INFANT HEEL WARMERCoopersurgical, Inc.MPO2022-11-29
10850046230094Future Generation Medical Global International L. L. C.MPO2022-11-13
10850046230100Future Generation Medical Global International L. L. C.MPO2022-11-13
00850046230097Future Generation Medical Global International L. L. C.MPO2022-11-13