°M Warmer System - Starter Kit MWS005

GUDID 05745000140015

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 05745000140039) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).

Mequ A/S

Conduction blood/fluid warmer

• Primary Device ID: 05745000140015
• NIH Device Record Key: 7467b286-71e2-4156-823e-dedfae76f7e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: °M Warmer System - Starter Kit
• Version Model Number: MWS005
• Catalog Number: MWS005
• Company DUNS: 305297593
• Company Name: Mequ A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05745000140015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232107

FDA Product Code

• BSB: Warmer, Blood, Non-Electromagnetic Radiation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-07
• Device Publish Date: 2024-10-30

Devices Manufactured by Mequ A/S

• 05745000140015 - °M Warmer System - Starter Kit: 2024-11-07The °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 05745000140039) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).
• 05745000140015 - °M Warmer System - Starter Kit: 2024-11-07 The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral
• 05745000140022 - °M Warmer System - Starter Kit+: 2024-11-07 The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral
• 05700002076823 - °M Warmer System - °M Warmer: 2024-10-17 Disposable IV Fluid / Blood Warmer unit
• 05700002076847 - °M Warmer System - Charger: 2024-10-17 Charger for charging the Power Pack / Power Pack+ (rechargeable battery packs)
• 05745000140039 - °M Warmer System - Power Pack: 2024-10-17 Rechargeable battery pack for powering the °M Warmer
• 05745000140046 - °M Warmer System - Power Pack+: 2024-10-17 Rechargeable battery pack for powering the °M Warmer