FDA.reportPublic FDA data

Phoenix Healthcare Solutions LLC

Primary DI
00360913523011
Brand
Phoenix Healthcare Solutions LLC
Company
PHOENIX HEALTHCARE SOLUTIONS, LLC
Model
PHX-SV-01
Device description
Steam Vaporizer
Published
2023-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KFZHumidifier, Non-Direct Patient Interface (Home-Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFZHumidifier, Non-Direct Patient Interface (Home-Use)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00360913523011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360913523011003609135230113609135230110360913523011

GMDN Terms#

Term, Definition table
TermDefinition
Steam inhaler, electrically-poweredAn electrically-powered, hand-held device designed for the inhalation of steam for the relief of the symptoms (congestion and pressure) associated with upper respiratory disorders. It consists of a water tank with integrated water heater and an attached mask/mouthpiece.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079146847
Device count
1
Premarket exempt
true
Lot or batch
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
00194346604845EquateWAL-MART STORES, INC.KFZ2026-02-16
00328785008234HONEYWELLKAZ USA, INC.KFZ2026-02-04
00328785008258HoneywellKAZ USA, INC.KFZ2026-02-04
00328785012828VicksKAZ USA, INC.KFZ2026-02-04
00328785101539VicksKAZ USA, INC.KFZ2026-02-04
00328785002263HoneywellKAZ USA, INC.KFZ2026-02-04
10328785008231HONEYWELLKAZ USA, INC.KFZ2026-02-04
10328785008255HoneywellKAZ USA, INC.KFZ2026-02-04
00328785012804VicksKAZ USA, INC.KFZ2026-02-04
00328785012811VicksKAZ USA, INC.KFZ2026-02-04
10328785012825VicksKAZ USA, INC.KFZ2026-02-04
00328785012835VicksKAZ USA, INC.KFZ2026-02-04
10328785101536VicksKAZ USA, INC.KFZ2026-02-04
00328785008241HONEYWELLKAZ USA, INC.KFZ2026-02-03
00050428005583CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-28
00328785009620VICKSKAZ USA, INC.KFZ2026-01-28
00328785013863VicksKAZ USA, INC.KFZ2026-01-28
00328785014426VicksKAZ USA, INC.KFZ2026-01-28
00050428005606CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
10050428005603CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
00050428005613CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
10050428005610CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
10889483054338AirLife™SUNMED, LLCKFZ2025-12-19
10889483229422AirLife™SUNMED, LLCKFZ2025-12-19
20889483054335AirLife™SUNMED, LLCKFZ2025-12-19
20889483229429AirLife™SUNMED, LLCKFZ2025-12-19
10889483054321AirLife™SUNMED, LLCKFZ2025-12-18
00328785002454VicksKAZ, INC.KFZ2025-05-05
00328785002478VicksKAZ, INC.KFZ2025-05-05
00851440007704Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.KFZ2024-08-01