FDA.report

Hercules

Primary DI
00819552020004
Brand
Hercules
Company
MOREL COMPANY, LLC., THE
Model
DFSA3N
Catalog number
NA
Device description
33" Width Flat Deck Patient Repositioner
Published
2017-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819552020004PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
812-932-6100joe@morelcompany.com

Regulatory Flags

DUNS number
079202952
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00819552022336Hercules MattressMattress, Kap Medical, Pneumatic, Revision B, 35" MKPB542025-12-17
00819552022343Hercules Air Mattress ControllerController, Kap Medical, Revision ACKA2025-12-17
00819552020042HerculesDFSA9NA2017-12-13
00819552020059HerculesDVSA5NA2017-12-07

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