FDA.reportPublic FDA data

Fluido® AirGuard System

Primary DI
08719867002769
Brand
Fluido® AirGuard System
Company
The Surgical Company International B.V.
Model
671500-US
Device description
Fluido® Trauma Set US
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
08719867002769PackageGS115In Commercial Distribution
08719867002776PackageGS130In Commercial Distribution
08719867002752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719867002769087198670027698719867002769
08719867002776087198670027768719867002776
08719867002752087198670027528719867002752

GMDN Terms#

Term, Definition table
TermDefinition
Radiation blood/fluid warmer intravenous setA collection of devices used in conjunction with a radiation blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It typically consists of a pouch(es) or a flexible cassette through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
409656493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719867002790Fluido® AirGuard System651115-US2025-09-12
18719867001615Fluido® AirGuard System660200A2025-09-12
18719867001622Fluido® AirGuard System6603002025-09-12
18719867001646Fluido® AirGuard System6614002025-09-12
18719867001653Fluido® AirGuard System660500-B2025-09-12
18719867002254Fluido® AirGuard System671200-US2025-09-12
18719867002636Mistral-AirMA24552025-01-30
18719867002650Mistral-AirMA34552025-01-30
18719867000076Mistral-AirMA1200-US2025-01-30
18719867000212Mistral-AirMA05102025-01-30
18719867000540Mistral-AirMA22202025-01-30
18719867000595Mistral-AirMA22302025-01-30
18719867000632Mistral-AirMA22402025-01-30
18719867000663Mistral-AirMA22502025-01-30
18719867000717Mistral-AirMA22602025-01-30
18719867000755Mistral-AirMA22652025-01-30
18719867000793Mistral-AirMA22702025-01-30
18719867002056Mistral-AirMA22802025-01-30
18719867002063Mistral-AirMA22852025-01-30
18719867000908Mistral-AirMA22862025-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
00841027102434Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102830Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102847Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102854Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102861Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102878Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08