FDA.reportPublic FDA data

Fluido® AirGuard System

Primary DI
18719867001622
Brand
Fluido® AirGuard System
Company
The Surgical Company International B.V.
Model
660300
Device description
Fluido® Pressure Chambers
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251733000Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)2025-09-04LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18719867001622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1871986700162218719867001622

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, automatedA pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
409656493
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18719867001561Fluido® CompactWarming Module6502002024-02-09
18719867001776Fluido® CompactStandard Set6720002024-02-09
18719867001806Fluido® CompactStandard Set with Drip Chamber6721002024-02-09
18719867002421Fluido® CompactControl Module650100-US2024-02-09
08719867002752Fluido® AirGuard System671500-US2025-09-12
18719867002247Fluido® AirGuard System671200-US2025-09-12
08719867002769Fluido® AirGuard System671500-US2025-09-12
08719867002790Fluido® AirGuard System651115-US2025-09-12
18719867001615Fluido® AirGuard System660200A2025-09-12
18719867001646Fluido® AirGuard System6614002025-09-12
18719867001653Fluido® AirGuard System660500-B2025-09-12
18719867002254Fluido® AirGuard System671200-US2025-09-12
18719867000243Mistral-AirMA16102023-06-05
18719867000281Mistral-AirMA16202023-06-05
18719867000328Mistral-AirMA16302023-06-05
18719867000366Mistral-AirMA16402023-06-05
18719867000403Mistral-AirMA17102023-06-05
18719867000441Mistral-AirMA17202023-06-05
18719867000489Mistral-AirMA17302023-06-05
18719867000502Mistral-AirMA17402023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02
00841027104728Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104735Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104742Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104759Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
07540162042867HugAire 2 Cu.Ft.Single Compartment Warming CabinetImperial Surgical LtdLGZ2026-04-24
00724995153724AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153731AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153748AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153755AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153762AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153786AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153793AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153809AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995154165AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995158422AmscoSTERIS CORPORATIONLGZ2026-02-13
00841027101604Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102298Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102311Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102328Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102335Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102342Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102359Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102366Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102373Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102380Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102397Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102403Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102410Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102427Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08