FDA.reportPublic FDA data

Fullerton Manufacturing Limited

Primary DI
08936235650050
Brand
Fullerton Manufacturing Limited
Company
FULLERTON MANUFACTURING LIMITED
Model
1
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936235650050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936235650050089362356500508936235650050

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
673129590
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08936235650005Fullerton Manufacturing Limited12025-07-02
08936235650029Fullerton Manufacturing Limited12025-07-02
08936235650036Fullerton Manufacturing Limited12025-07-02
08936235650043Fullerton Manufacturing Limited12025-07-02
08936235650012Fullerton Manufacturing Limited12025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281031875Dependa-Bar, Brushed Stainless SteelHealthcraft Products Inc.IKX2026-09-22
00689281037372Dependa-Bar, Polished ChromeHealthcraft Products Inc.IKX2026-09-22
00689281037389Dependa-Bar, Smooth WhiteHealthcraft Products Inc.IKX2026-09-22
00689281037457PLUS Shampoo Shelf 24 + Grab Bar, Matte BlackHealthcraft Products Inc.IKX2026-09-22
00689281037464PLUS Shampoo Shelf 24 + Grab Bar, Brushed StainlessHealthcraft Products Inc.IKX2026-09-22
00689281037471PLUS Shampoo Shelf 24 + Grab Bar, Chrome PolishedHealthcraft Products Inc.IKX2026-09-22
00689281039598PLUS Shampoo Shelf 24 + Grab Bar, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-09-22
06975996304064Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304071Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304088Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304095Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304101Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
00810226441989ViveVIVE HEALTH LLCIKX2026-08-14
06974021419490EQUATEWAL-MART STORES, INC.IKX2026-07-31
10194484320772CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320789CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320796CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320802CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320819CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320826CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320833CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320840CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320857CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320864CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320871CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320895CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320901CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320918CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320925CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320932CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30