Level 1 - DI-300
Device Description
An electrically-powered device designed for in-line heating of rapidly-infused (may exceed 1 L/min) banked blood, blood products, and intravenous (IV) solutions (crystalloid and colloid), typically from about 4ºC to near body temperature (i.e., 35 to 37ºC), during high-blood-loss surgical procedures and for burn and trauma cases. The device usually includes an aqueous heat exchanger (e.g., water bath) for the convection of heat to the infusion blood/fluid via a disposable set (e.g., coiled tubing); 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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KZL
Device Name: Device, Warming. Blood And Plasma
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.9205
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 50695085430016
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20695085430015
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 20695085430015
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.
GMDN ®. © GMDN Agency 2005-.