FDA.reportPublic FDA data

Hercules

Primary DI
M988DFSA3N
Brand
Hercules
Company
MOREL COMPANY, LLC., THE
Model
DFSA3N
Catalog number
NA
Device description
"33"" Width Flat Patient Repositioner"
Published
2017-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
M988DFSA3NPrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(812) 932-6100joe@morelcompany.com

Regulatory Flags#

DUNS number
079202952
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819552022473Advanced Wave HX, Hercules Mattress SystemRevision B2026-04-08
00819552022336Hercules Mattress"Mattress, Kap Medical, Pneumatic, Revision B, 35"MKPB542025-12-17
00819552022343Hercules Air Mattress ControllerController, Kap Medical, Revision ACKA2025-12-17
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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08592654134481Eleganza 5L I N E T spol. s r.o.FNL2018-04-09