FDA.reportPublic FDA data

Sammons Preston

Primary DI
00885914108048
Brand
Sammons Preston
Company
Performance Health Supply, LLC
Model
7033860
Catalog number
382145
Device description
"Sammons Preston Instant Hot Pack, Infant Heel, 4""x 4.4"", EA"
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10885914108045PackageGS125In Commercial Distribution
20885914108042PackageGS1100In Commercial Distribution
00885914108048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088591410804510885914108045
2088591410804220885914108042
00885914108048008859141080488859141080480885914108048

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966806150
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885914040461Rolyan0813016392026-03-20
00885914040478Rolyan081301647N/A2026-03-20
00885914040485Rolyan081301654N/A2026-03-20
00885914004050METRON3030013030012016-09-16
00885914022023METRON9220999220992016-09-16
10885914075927METRON5687825687822017-01-31
10885914077440Performa0817107550817107552017-10-12
00885914077436Performa0817107480817107482017-10-13
00885914107898Sammons Preston70338453821302026-01-23
00885914107966Sammons Preston70338523821372026-01-23
00885914107973Sammons Preston70338533821382026-01-23
00885914107980Sammons Preston70338543821392026-01-23
00885914107997Sammons Preston70338553821402026-01-23
00885914108000Sammons Preston70338563821412026-01-23
00885914108017Sammons Preston70338573821422026-01-23
00885914108024Sammons Preston70338583821432026-01-23
00885914108031Sammons Preston70338593821442026-01-23
00885914108055Sammons Preston70338613821462026-01-23
00885914108062Sammons Preston 70338623821472026-01-23
00885914108079Sammons Preston70338633821482026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850046230097Future Generation Medical Global International L. L. C.MPO2022-11-13