FDA.report

MEDZAH INFANT HEEL WARMER

Primary DI
20860011917490
Company
Medzah Industries
Model
SAM-108
Device description
Infant Heel Warmer 5.5x3.75 inch
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
114193536
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20860011917490PackageGS14In Commercial Distribution
10860011917493PrimaryGS10
00860011917496Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20860011917490PackageGS1410860011917493In Commercial Distribution
10860011917493PrimaryGS10
00860011917496Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MPOInfant Heel Warmer (Chemical Heat Pack)1Physical Medicine890.5710NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(860)288-8696info@medzah.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10860010472146Instant Cold Pack 6inx9inSAM-10012025-08-11
20860012637410Instant Cold Pack 4.75x7SAM-30002025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inSAM-30012025-08-11
20860011343879BIONEXBNMD012025-07-30
20860011343886BIONEXBNMD022025-07-30
20860011343893BIONEXBNMD032025-07-30
20860011725408BIONEXBNMD042025-07-30
20860011725415BIONEXBNMD052025-07-30
20860011917483MEDZAH INSTANT HOT PACKSAM-20002025-07-30
20860012637403MEDZAH INSTANT HOT PACKSAM-20012025-07-30
00860009922730Medzah Steel Walkers with 5" WheelsMDZH904SE2025-03-07
00860009784895Ditek Urine Collection CupCP102212025-03-06
00860012637430SnapnSealEVON1022025-03-06
00850070779050MNG 5-Tube CSF Collection1252182024-12-03
00850070779067MNG TRIO Blood Testing1252202024-12-03
00850070779074MNG Single Blood Genetic Test1252212024-12-03
00850070779081MNG Buccal Swab1252222024-12-03
00850070779098MNG Blood Enzymology Testing1252232024-12-03
00850070779104MNG - PTC Collection Kit1337192024-12-03
00850070779111MNG - RNA Sequencing Collection Kit1389572024-12-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00885914108048Sammons PrestonPerformance Health Supply, LLCMPO2026-01-23
40080196749967MEDLINEMEDLINE INDUSTRIES, INC.MPO2025-10-21
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