FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756312924
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
HNICU-100
Catalog number
HNICU-100
Device description
Infant Heel Warmer
Published
2021-07-09
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

Contact Domains#

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
30749756312920PackageGS125In Commercial Distribution
50749756312924PackageGS1100In Commercial Distribution
00749756312929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975631292030749756312920
5074975631292450749756312924
00749756312929007497563129297497563129290749756312929

GMDN Terms#

Term, Definition table
TermDefinition
Exothermic heat therapy pack/patchA device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
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
true
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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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
10192253061468NOVAPLUSCardinal Health 200, LLCMPO2023-02-27
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