Life Warmer Quantum Blood and Fluid Warming System

Primary DI
00868058000485
Brand
Life Warmer Quantum Blood and Fluid Warming System
Company
NORTH AMERICAN RESCUE, LLC
Model
63-5900
Catalog number
35-0006
Device description
The Lifewarmer Quantum Blood and Fluid Warming System is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management.The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death.Quantum System Contents:1 x Controller1 x Battery1 x Battery Charger2 x TTS-B (Thermal Transfusion Set - Blood)NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide
Published
2019-09-03
Public version status
Update
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
K181775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181775000Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.2019-01-28LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868058000485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868058000485008680580004858680580004850868058000485

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerA mains electricity (AC-powered) device, which may include rechargeable batteries, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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00842209138913NAR82-0049A82-0049A2026-05-27
00842209138920NAR82-0053A82-0053A2026-05-27
00842209138937NAR80-1907A80-1907A2026-05-27
00842209138944NAR80-192980-19292026-05-27
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