FDA.reportPublic FDA data

AFCS PEARLS™ Control unit

Primary DI
08720387388004
Brand
AFCS PEARLS™ Control unit
Company
Synergie Nederland B.V.
Model
SAT2
Catalog number
2010002-US
Device description
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit
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
08720387388004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720387388004087203873880048720387388004

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
417294923
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
08720387388134AFCS PEARLS™ Traction support poleSAT2 / SAT120103172021-08-20
08720387388011AFCS PEARLS™ Bed unitSAT22010003-US2021-08-20
08720387388028AFCS PEARLS™ Extension HoseSAT22010310-US2021-08-20
08720387388035AFCS PEARLS™ Air filterSAT220106012021-08-20
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
B627AF10000Resurg Air Fluidized Therapy SystemAuxilium Medical Inc.INX2026-11-01
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
00887761013834Envella™ BedHILL-ROM, INC.INX2016-09-17
00887761996823Patient HelperHILL-ROM, INC.INX2016-09-17