FDA.reportPublic FDA data

Hercules Mattress

Primary DI
00819552022336
Brand
Hercules Mattress
Company
MOREL COMPANY, LLC., THE
Model
"Mattress, Kap Medical, Pneumatic, Revision B, 35"
Catalog number
MKPB54
Device description
"Hercules Patient Repositioner with Mattress Pneumatic, Revision B, 35"" Width, 84"" Length"
Published
2025-12-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819552022336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819552022336008195520223368195520223360819552022336

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric hospital bedA mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length84Inch
Width35Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079202952
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819552022473Advanced Wave HX, Hercules Mattress SystemRevision B2026-04-08
00819552022343Hercules Air Mattress ControllerController, Kap Medical, Revision ACKA2025-12-17
M988DFSA3NHerculesDFSA3NNA2017-02-12
M988DFSA3RHerculesDFSA3RNA2017-02-12
M988DFSA5HerculesDFSA5NA2016-05-11
M988DFSA9HerculesDFSA9NA2016-05-11
M988DVSA5HerculesDVSA5NA2016-05-11
00819552020004HerculesDFSA3NNA2017-12-07
00819552020042HerculesDFSA9NA2017-12-13
00819552020059HerculesDVSA5NA2017-12-07

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Primary DI, Brand, Company table
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