FDA.reportPublic FDA data

Infant Heel Warmer

Primary DI
00850018561594
Brand
Infant Heel Warmer
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
1223
Catalog number
1223
Device description
Infant Heel Warmer
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221154000Infant Heel WarmerTM; Heel Snuggler®International Biomedical2022-10-07MPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018561594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018561594008500185615948500185615940850018561594

GMDN Terms#

Term, Definition table
TermDefinition
Activated-medium surgical warming blanketA non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover. It is a highly hygienic device made of plastic material and designed with integrated pockets that hold air-activated warming pads containing various media [e.g., active coal, clay, or salt and iron (Fe) powder] that chemically generate heat when the device is removed from its sealed packaging. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073179368
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Delivery Lines415-00012026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Sample Lines415-00002026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Bagger415-00022026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Bagger731-99192026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx NO Supply Hose731-18622026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Kit731-02742026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Test Circuit738-18892026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Circuit738-18502026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Kit731-91472026-10-19
00850018561006ECG Patient CableECG Patient Cable711-00142026-10-13
00850018561037Gel-E DonutGEL-E DONUT, MEDIUM (CASE OF 12)9898031963912026-10-13
00850018561044Gel-E DonutGEL-E DONUT, EXTRA SMALL (CASE OF 12)9898031963712026-10-13
00850018561051Gel-E DonutGEL-E DONUT, SMALL (CASE OF 12)9898031963812026-10-13
00850018561068SquishonSquishon 2 Gel Pillow, 12/pk9898031963612026-10-13
00850018561075SquishonSquishon Mattress9898056033012026-10-13
00850018561082SquishonSquishon 3 Gel Pillow, 12/pk9898056064612026-10-13
00850018561105WeeSpecsWeeSpecs, Small (28-34 cm), 50/pk9898056076412026-10-13
00850018561136WeeSpecsWeeSpecs Supreme Small, 50/pk9898056041612026-10-13
00850018561143WeeSpecsWeeSpecs Supreme, Medium, 50/pk9898056042112026-10-13
00850018561150WeeSpecsWeeSpecs Supreme, Preemie, 50/pk9898056076312026-10-13

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
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