°M Warmer System - °M Warmer

Primary DI
05700002076823
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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSBWarmer, Blood, Non-Electromagnetic Radiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305297593
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05700002076816°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

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