FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216119291
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
INFHW-ASP
Device description
HEEL WARMER, INFANT, SINGLE USE, LATEX FREE, 25EA/BX, 4BX/CS (100EA/CS)
Published
2022-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00840216119291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216119291008402161192918402161192910840216119291

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
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22
00840216107007ASP MEDICALIWA03-D2022-07-22

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