FDA.reportPublic FDA data

Fluido® AirGuard System

Primary DI
18719867001653
Brand
Fluido® AirGuard System
Company
The Surgical Company International B.V.
Model
660500-B
Device description
Fluido® IV-Pole
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
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
18719867001653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1871986700165318719867001653

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding/bed-attached intravenous poleA freestanding or equipment-attached metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Also called an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed, operating table, wheelchair, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels for patient mobility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
409656493
Device count
1
Lot or batch
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
18719867001622Fluido® AirGuard System6603002025-09-12
18719867001646Fluido® AirGuard System6614002025-09-12
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
B286DWC243074TGRMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-10-05
B286SWC243074MBST1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-30
B286DWC183074TLG4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-18
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02