AccessGUDID - DEVICE: °M Warmer System - Starter Kit+ (05745000140022)

GUDID

Device Identifier (DI) Information

Brand Name: °M Warmer System - Starter Kit+
Version or Model: MWS006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MWS006
Company Name: Mequ A/S

Primary DI Number: 05745000140022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305297593 *Terms of Use

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).

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47616	Conduction blood/fluid warmer	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSB	Warmer, Blood, Non-Electromagnetic Radiation
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232107	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4a3ad9d-7f94-459b-bfe8-9bad9978586a
Public Version Date: November 07, 2024
Public Version Number: 1
DI Record Publish Date: October 30, 2024