FDA.reportPublic FDA data

Phoenix Healthcare Solutions LLC

Primary DI
00360913522014
Brand
Phoenix Healthcare Solutions LLC
Company
PHOENIX HEALTHCARE SOLUTIONS, LLC
Model
PHX-AM-01
Device description
Air Mattress
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00360913522014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360913522014003609135220143609135220140360913522014

GMDN Terms#

Term, Definition table
TermDefinition
Flotation therapy bed, adultA mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079146847
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817096001404Optisource74-0323-A2024-08-18
00817096001411Optisource74-0323-B2024-08-18
00817096001428Optisource74-0323-C2024-08-18
00817096001435Optisource74-0323-G2024-08-18
00817096001442Optisource74-0323-O2024-08-18
00817096001459Optisource74-0323-W2024-08-18
00817096001466Optisource74-0700-A2024-08-18
00817096001473Optisource 74-0700-BK2024-08-18
00817096001480Optisource74-0700-BL2024-08-18
00817096001497Optisource74-0700-G2024-08-18
00817096001503Optisource74-0700-O2024-08-18
00817096001510Optisource74-0700-W2024-08-18
00817096001527Optisource74-1050-A2024-08-18
00817096001534Optisource74-1050-B2024-08-18
00817096001541Optisource74-1050-C2024-08-18
00817096001558Optisource74-1050-G2024-08-18
00817096001565Optisource74-1050-O2024-08-18
00817096001572Optisource74-1050-W2024-08-18
00360913027014Phoenix Healthcare Solutions LLC CL-012023-09-05
00360913028011Phoenix Healthcare Solutions LLC CL-022023-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810055885695DOLPHIN FIS 48X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885701SYSTEM, DLPH PEDIATRIC CRIB, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMJOERNS HEALTHCARE, LLCFNM2026-08-26
00810226442016ViveVIVE HEALTH LLCFNM2026-08-19
00810226442023ViveVIVE HEALTH LLCFNM2026-08-19
00810226442030ViveVIVE HEALTH LLCFNM2026-08-19
00850076421106ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421113ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421120ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421137ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
H93359076Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-07-27
04719876192011TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-09
04719876190048TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190215TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190482TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190499TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876191991TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192004TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192202TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192219TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
00841447116745Invacare MA500X4280MINVACARE CORPORATIONFNM2026-07-01
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.FNM2026-06-09
00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-4 D3XKAP MEDICALFNM2026-05-29
00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13