FDA.reportPublic FDA data

MEDLINE

Primary DI
40080196749967
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDS139007
Catalog number
MDS139007
Device description
PACK,HOT,INSTANT,6"X6"
Published
2025-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
40080196749967PackageGS136In Commercial Distribution
00080196749969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4008019674996740080196749967
00080196749969000801967499690801967499690080196749969

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885914108048Sammons PrestonPerformance Health Supply, LLCMPO2026-01-23
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
20192253061427CARDINAL HEALTHCARDINAL HEALTH 200, LLCMPO2023-02-21
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