AFCS PEARLS™ Air filter

Primary DI
08720387388035
Brand
AFCS PEARLS™ Air filter
Company
Synergie Nederland B.V.
Model
SAT2
Catalog number
2010601
Device description
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air filter
Published
2021-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08720387388035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720387388035087203873880358720387388035

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

Regulatory Flags#

DUNS number
417294923
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720387388134AFCS PEARLS™ Traction support poleSAT2 / SAT120103172021-08-20
08720387388004AFCS PEARLS™ Control unitSAT22010002-US2021-08-20
08720387388011AFCS PEARLS™ Bed unitSAT22010003-US2021-08-20
08720387388028AFCS PEARLS™ Extension HoseSAT22010310-US2021-08-20
08720387388042AFCS PEARLS™ Filter sheet large multifilamentSAT220106022021-08-20
08720387388059AFCS PEARLS™ Filter sheet small multifilamentSAT220106042021-08-20
08720387388066AFCS PEARLS™ Filter sheet large monofilamentSAT220106052021-08-20
08720387388073AFCS PEARLS™ Filter sheet small monofilamentSAT220106062021-08-20
08720387388110AFCS PEARLS™ & SANDS™ Corner clampsSAT1 / SAT220103112021-08-20
08720387388127AFCS PEARLS™ Control unitSAT220103122021-08-20
08720387388141AFCS PEARLS™ BackrestSAT220103162021-08-20

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
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
00887761013834Envella™ BedHILL-ROM, INC.INX2016-09-17
00887761996823Patient HelperHILL-ROM, INC.INX2016-09-17