FDA.reportPublic FDA data

°M Warmer System - Starter Kit+

Primary DI
05745000140022
Brand
°M Warmer System - Starter Kit+
Company
Mequ A/S
Model
MWS006
Catalog number
MWS006
Device description
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).
Published
2024-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
05745000140022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000140022057450001400225745000140022

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305297593
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05745000140015°M Warmer System - Starter KitMWS005MWS0052024-10-30
05700002076816°M Warmer System - °M WarmerMWS201MWS2012024-10-09
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
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
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