FDA.reportPublic FDA data

°M Warmer System - °M Warmer

Primary DI
05700002076816
Brand
°M Warmer System - °M Warmer
Company
Mequ A/S
Model
MWS201
Catalog number
MWS201
Device description
Disposable IV Fluid / Blood Warmer unit
Published
2024-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSBWarmer, Blood, Non-Electromagnetic Radiation
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232107000°M Warmer SystemMequ A/S2024-05-31LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700002076816PrimaryGS10
05700002076823Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700002076816057000020768165700002076816
05700002076823057000020768235700002076823

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerAn electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure60 KiloPascal106 KiloPascal
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Regulatory Flags#

DUNS number
305297593
Device count
5
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05745000140015°M Warmer System - Starter KitMWS005MWS0052024-10-30
05745000140022°M Warmer System - Starter Kit+MWS006MWS0062024-10-30
05700002076823°M Warmer System - °M WarmerMWS201MWS2012024-10-09
05700002076847°M Warmer System - ChargerMWS301MWS3012024-10-09
05745000140039°M Warmer System - Power PackMWS105MWS1052024-10-09
05745000140046°M Warmer System - Power Pack+MWS106MWS1062024-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
507073878034023M™ Ranger™3M COMPANYBSB2026-04-26
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