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
00689281037396Wave Grab Bar, 18" Length, Left and Right, Matte Black (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281037402Wave Grab Bar, 18" Length, Left and Right, Brushed Stainless (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281037419Wave Grab Bar, 18" Length, Left and Right, Polished Chrome (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281038065Wave Grab Bar, 1.25x18" Length, Matte BlackHealthcraft Products Inc.IKX2026-10-13
00689281038072Wave Grab Bar, 1.25x18" Length, Brushed StainlessHealthcraft Products Inc.IKX2026-10-13
00689281038089Wave Grab Bar, 1.25x18" Length, Brushed GoldHealthcraft Products Inc.IKX2026-10-13
00689281038096Wave Grab Bar, 1.25x18" Length, Polished ChromeHealthcraft Products Inc.IKX2026-10-13
00689281038348Wave Grab Bar, 18" Length, Left and Right, Brushed Gold (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281039413Wave Grab Bar, 1.25x18" Length, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-10-13
00810226442962ViveVIVE HEALTH LLCIKX2026-10-12
00689281039604Easy Mount™ Grab Bar, Modular L-Shape, 1.25x16x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039611Easy Mount™ Grab Bar, Modular L-Shape, 1.25x24x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039628Easy Mount™ Grab Bar, Modular L-Shape, 1.25x30x30", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008105Easy Mount™ Grab Bar, 1.25x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008112Easy Mount™ Grab Bar, 1.25x32", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008129Easy Mount™ Grab Bar, 1.25x36", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008136Easy Mount™ Grab Bar, 1.25x42", KnurledHealthcraft Products Inc.IKX2026-09-30