FDA.reportPublic FDA data

Level 1

Primary DI
20695085470103
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
IR-700
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
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
20695085470103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2069508547010320695085470103

GMDN Terms#

Term, Definition table
TermDefinition
Heat-exchanging intravenous administration setA collection of noninvasive devices designed to directly warm and conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It does not include devices intended to be used invasively. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
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