FDA.reportPublic FDA data

Envella™ Bed

Primary DI
00887761013834
Brand
Envella™ Bed
Company
HILL-ROM, INC.
Model
P0819A
Device description
Hospital Bed
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
INXBED, AIR FLUIDIZED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INXBed, Air FluidizedPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761013834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761013834008877610138348877610138340887761013834

GMDN Terms#

Term, Definition table
TermDefinition
Air-fluidized bedA mains electricity (AC-powered) bed designed for the treatment of severely and extensively burned patients. It may also be used in cases of decubitus ulcers or where the patient has little remaining body fat (extreme anorexia) and the displacement of the body weight is vital. It employs the circulation of filtered and temperature-regulated air forced through large quantities of ceramic spherules (small round beads) which become transformed from a solid mass into an almost liquid (fluidized) state, providing the patient with complete uplift over the whole supine body surface. Other beneficial effects are the drying of wound seepage and reduction of infection risk.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
004245668
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521014476ALLEN102001F-LH5002023-05-30
00615521015299ALLEN900111F-TWE2BER2023-05-31
00615521014650ALLEN102001F-LHPBMAQNP2023-05-30
00615521014803ALLEN102007F-NTSHDE2023-05-30
00615521014810ALLEN102007F-NTSHDUK2023-05-30
00615521031473ALLEN102001I-LHMM2023-05-30
00615521013790ALLEN107002F-ABSLT2BER2023-05-26
00615521014391ALLEN102005F-FBD850BER2023-05-26
00615521014735ALLEN102005F-MDTPTB32023-05-26
00615521014889ALLEN102004F-PSTBHD2023-05-26
00615521015015ALLEN103002F-SFPASBER2023-05-26
00615521015046ALLEN102005F-SLD850BER2023-05-26
00615521014599ALLEN102001F-LHMAQ2023-05-30
00615521031459ALLEN102001F-10056MAQ2023-05-30
00615521031466ALLEN102001F-10057MAQ2023-05-30
00615521012649ALLEN106002F-100152023-05-26
00615521013783ALLEN107002F-ABSLT2023-05-26
00615521014506ALLEN102001F-LH720MAQ2023-05-26
00615521002848ALLEN1030062026-04-24
00615521031008ALLEN1010052026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720387388004AFCS PEARLS™ Control unitSynergie Nederland B.V.INX2021-08-20
08720387388011AFCS PEARLS™ Bed unitSynergie Nederland B.V.INX2021-08-20
08720387388028AFCS PEARLS™ Extension HoseSynergie Nederland B.V.INX2021-08-20
08720387388035AFCS PEARLS™ Air filterSynergie Nederland B.V.INX2021-08-20
08720387388042AFCS PEARLS™ Filter sheet large multifilamentSynergie Nederland B.V.INX2021-08-20
08720387388059AFCS PEARLS™ Filter sheet small multifilamentSynergie Nederland B.V.INX2021-08-20
08720387388066AFCS PEARLS™ Filter sheet large monofilamentSynergie Nederland B.V.INX2021-08-20
08720387388073AFCS PEARLS™ Filter sheet small monofilamentSynergie Nederland B.V.INX2021-08-20
08720387388110AFCS PEARLS™ & SANDS™ Corner clampsSynergie Nederland B.V.INX2021-08-20
08720387388127AFCS PEARLS™ Control unitSynergie Nederland B.V.INX2021-08-20
08720387388134AFCS PEARLS™ Traction support poleSynergie Nederland B.V.INX2021-08-20
08720387388141AFCS PEARLS™ BackrestSynergie Nederland B.V.INX2021-08-20
B2844200002HU1HYDROAIREAURORA MANUFACTURING, LLCINX2017-02-17
B2844200002INST1HYDROAIREAURORA MANUFACTURING, LLCINX2017-02-17
00887761996823Patient HelperHILL-ROM, INC.INX2016-09-17