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

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
00887761943131Voalte Nurse Call4.22026-09-28
00887761012172Centrella™ SurfaceP7933A192026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B627AF10000Resurg Air Fluidized Therapy SystemAuxilium Medical Inc.INX2026-11-01
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