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FDA 510(k)

Quantum Blood and IV Fluid Infusion Warmer

K-Number: K181775 · 2019-01-28

ApplicantLife Warmer, Inc.
Decision Date2019-01-28
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Quantum Blood and IV Fluid Infusion Warmer is a medical device manufactured by Life Warmer, Inc.. It received FDA 510(k) clearance on 2019-01-28 under approval number K181775. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Blood and IV Fluid Infusion Warmer?

Quantum Blood and IV Fluid Infusion Warmer is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by Life Warmer, Inc.. The 510(k) number is K181775.

When was Quantum Blood and IV Fluid Infusion Warmer approved by the FDA?

Quantum Blood and IV Fluid Infusion Warmer received FDA 510(k) clearance on 2019-01-28, under approval number K181775.

What company makes Quantum Blood and IV Fluid Infusion Warmer?

Quantum Blood and IV Fluid Infusion Warmer is manufactured by Life Warmer, Inc..

What is the FDA product code for Quantum Blood and IV Fluid Infusion Warmer?

The FDA product code for Quantum Blood and IV Fluid Infusion Warmer is LGZ.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07610642 Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers NOT_YET_RECRUITING NCT02543983 Neurobiology of Suicide RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING

Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Life Warmer, Inc.

K192325Quantum Blood and Fluid Warming System

Related Devices (Code: LGZ)

K161613Hang&Go PACRand S.R.L. K150404QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K171215QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K163708QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K180154QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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