FDA.reportPublic FDA data

Future Generation Medical

Primary DI
10850046230100
Brand
Future Generation Medical
Company
Global International L. L. C.
Model
FG-IHW-5003A
Device description
Infant Heel Warmers - W/O Metal Disc
Published
2022-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053254000INFANT HEEL WARMER BY INTCOShanghai Intco Medical Supply Co., Ltd.2006-09-19MPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046230100PrimaryGS10
00850046230103Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004623010010850046230100
00850046230103008500462301038500462301030850046230103

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
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
(888) 291-7638info@fgmmedical.com

Regulatory Flags#

DUNS number
079251688
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850046230032Future Generation Medical FGMHOT04052022-11-13
10850046230049Future Generation Medical FGMHOT0425 2022-11-13
10850046230094Future Generation Medical FG-IHW-50032022-11-13
10850046230247Future Generation Medical FGTS-85912022-11-13
10850046230254Future Generation Medical FGTS-8591A2022-11-13
10850046230261Future Generation Medical FGGTS-65912022-11-13
10850046230278Future Generation Medical FG-HCP09162022-11-13
10850046230315Future Generation Medical FGM-D07262022-11-21
10850046230322Future Generation Medical FGM-D03152022-11-21
10850046230339Future Generation Medical FGM-D08242022-11-21
20850046230305Future Generation Medical FGM-D18472022-11-21
10850046230148Future Generation Medical AL29SQ2022-12-05
10850046230155Future Generation Medical AL27SQ2022-12-05
10850046230162Future Generation Medical AL26SQ2022-12-05
10850046230179Future Generation Medical AL25SQ2022-12-05
10850046230186Future Generation Medical AL22SQ2022-12-05
10850046230193Future Generation Medical AL20SQ2022-12-05
10850046230209Future Generation Medical AL19SQ2022-12-05
10850046230216Future Generation Medical AL18SQ2022-12-05
00850046230141Future Generation Medical AL29SQ2022-12-05

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
00850046230097Future Generation Medical Global International L. L. C.MPO2022-11-13