Panels › General Hospital › Product code LGZ · Class 2
Warmer, Thermal, Infusion Fluid
Regulation 880.5725
3510(k)s in 12 months (76 all time)
1recalls in 12 months (33 all time)
31recalls that name a 510(k)
Top companies in LGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 13 |
| Belmont Instrument Corp. | 6 | 4 |
| Quality IN Flow , Ltd. | 5 | 0 |
| Smisson-Cartledge Biomedical, LLC | 2 | 3 |
| Rand S.R.L. | 2 | 2 |
| STERIS Corporation | 3 | 1 |
| C.F. Electronics, Inc. | 3 | 0 |
| Medical Solutions, Inc. | 3 | 0 |
| Arizant Healthcare, Inc. | 2 | 0 |
| Automatic Medical Technologies, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2026 | ICU Medical Inc. Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow Open, Classified |
LGZ | K911383 |
| Aug 1, 2025 | 3M Company 3M Ranger Irrigation Fluid Warming Set, REF 24750 Open, Classified |
LGZ | K060939 |
| Apr 25, 2025 | Belmont Instrument LLC Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-000 Open, Classified |
LGZ | K152208 |
| Apr 25, 2025 | Belmont Instrument LLC 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032.
The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The Open, Classified |
LGZ | K242735 |
| Apr 25, 2025 | Belmont Instrument LLC Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) Open, Classified |
LGZ | K152208 |
| Apr 25, 2025 | Belmont Instrument LLC Hyperthermia Pump Procedure Kit. Model Number: 902-00045.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Open, Classified |
LGZ | K152208 |
| Aug 6, 2021 | Smiths Medical ASD Inc. NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700 Open, Classified |
LGZ | K072080 |
| Aug 6, 2021 | Smiths Medical ASD Inc. NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 Open, Classified |
LGZ | K072080 |
| Jun 4, 2021 | Eight Medical International BV Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a t Terminated |
LGZ | K102900 |
| Apr 30, 2021 | RanD S.r.l. Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter. Terminated |
LGZ | None listed |
| Apr 30, 2021 | RanD S.r.l. Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 Terminated |
LGZ | K161613 |
| Mar 26, 2021 | Smisson-Cartledge Biomedical, LLC ThermaCor 1200 Disposable Sets
Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including p Terminated |
LGZ | K052055 |
| Mar 26, 2021 | Smisson-Cartledge Biomedical, LLC ThermaCor 1200 Disposable Sets
Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including p Terminated |
LGZ | K052055 |
| Mar 26, 2021 | Smisson-Cartledge Biomedical, LLC ThermaCor 1200 Disposable Sets
Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including pa Terminated |
LGZ | K052055 |
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | K060537 K130867 |
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | K060537 K130867 |
| Oct 31, 2016 | Smiths Medical ASD, Inc. HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's Terminated |
LGZ | None listed |
| Oct 15, 2016 | Natus Manufacturing Limited Natus Warmette Blanket Cabinet and Warmette Dual Cabinet
The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is design Terminated |
LGZ | K132110 |
| Nov 20, 2015 | Steris Corporation AMSCO Warming Cabinet. Manufactured by: STERIS Corporation
To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obst Terminated |
LGZ | K111870 |
| Apr 9, 2014 | Smiths Medical ASD, Inc. Smiths Medical HOTLINE Fluid Warming Set L-80.
Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity
conditions Terminated |
LGZ | K911383 |
| Apr 9, 2014 | Smiths Medical ASD, Inc. Smiths Medical HOTLINE Fluid Warming Set L-70.
Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions Terminated |
LGZ | K911383 |
| Jul 9, 2012 | Vital Signs Devices, a GE Healthcare Company enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL
100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY,
MODEL 120).
The Enginivity enFlow TM IV Fluid Warmer is intended Terminated |
LGZ | K060537 |
| Jul 9, 2012 | Smiths Medical ASD, Inc. Smiths Medical HOTLINE 3 Blood and Fluid Warmer,
Reorder Numbers: HL-390
Product Usage:
The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOT Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. Level 1 Normothermic I.V. Fluid Administration Sets,
Product Code DI-60HL ,
Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. Level 1 Normothermic I.V. Fluid Administration Sets,
Product Code D-60HL ,
Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets,
Product Code L-80
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood an Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets,
Product Code L-370
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood a Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets,
Product Code L-270
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood a Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets, Product Codes L-70NI
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood Terminated |
LGZ | K911383 |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets, Product Codes L-70
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood an Terminated |
LGZ | K911383 |
| Aug 19, 2011 | Vital Signs Devices, a GE Healthcare Company enFlow IV Fluid Warmer Part number 980105VS;
(510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120)
Intended for warming blood, blood Terminated |
LGZ | K060537 |
| Sep 3, 2010 | Vital Signs Inc Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids. Terminated |
LGZ | K060537 |
| Sep 4, 2009 | Enginivity LLC Model 100 enFlow Fluid/Blood Warmer
Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156
The device is a medical point-of-care device designed to warm blood and IV fluids. Terminated |
LGZ | K060537 |
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