FDA.reportPublic FDA data

Level 1

Primary DI
50695085812904
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
H-1129
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K072080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072080000NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,Smiths Medical Asd, Inc.2008-06-02LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50695085812904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5069508581290450695085812904

GMDN Terms#

Term, Definition table
TermDefinition
Convection blood/fluid warmer, high-flowA mains electricity (AC-powered) device designed for in-line heating of rapidly-infused (may exceed 1 L/min) banked blood, blood products, and intravenous (IV) solutions (crystalloid and colloid), typically from about 4?C to near body temperature (i.e., 35 to 37?C), during high-blood-loss surgical procedures and for burn and trauma cases. The device usually includes an aqueous heat exchanger (e.g., water bath) for the convection of heat to the infusion blood/fluid via a disposable set (e.g., coiled tubing); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

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