Panels › Anesthesiology › Product code BTL · Class 2
Ventilator, Emergency, Powered (Resuscitator)
Regulation 868.5925
0510(k)s in 12 months (100 all time)
0recalls in 12 months (29 all time)
27recalls that name a 510(k)
Top companies in BTL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Mercury Enterprises, Inc. dba Mercury Medical Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842 Open, Classified |
BTL | K093913 |
| Oct 2, 2024 | Mercury Enterprises, Inc. dba Mercury Medical Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support. Open, Classified |
BTL | K093913 |
| Sep 20, 2024 | Smiths Medical ASD Inc. paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N Open, Classified |
BTL | K123957 |
| Sep 20, 2024 | Smiths Medical ASD Inc. paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Open, Classified |
BTL | K123957 |
| Sep 11, 2024 | Smiths Medical ASD Inc. Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX Open, Classified |
BTL | K123957 |
| Sep 11, 2024 | Smiths Medical ASD Inc. Pneupac paraPAC plus 300 ventilator kit, REF P300NXX Open, Classified |
BTL | K123957 |
| Mar 19, 2024 | Smiths Medical ASD Inc. smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS Open, Classified |
BTL | K123957 |
| Mar 19, 2024 | Smiths Medical ASD Inc. smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS Open, Classified |
BTL | K123957 |
| Jul 15, 2021 | Smiths Medical ASD Inc. Pneupac paraPac plus 300 ventilator kit, REF P300NGB Terminated |
BTL | K123957 |
| Jun 26, 2020 | Precision Valve & Automation,Inc PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to prov Open, Classified |
BTL | None listed |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e700 Automatic Transport Ventilator, Model Number 01EVE700 Terminated |
BTL | K141595 |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e600 Automatic Transport Ventilator, Model Number 01EVE600 Terminated |
BTL | K141595 |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e500 Automatic Transport Ventilator, Model Number 01EVE500 Terminated |
BTL | K141595 |
| Apr 25, 2017 | Vortran Medical Technology 1, Inc VORTRAN Automatic Resuscitator, VARPlus with Extension Kit;
Model PCE-5012; Qty: 10 each.
Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, con Terminated |
BTL | K001430 K041473 +1 |
| Apr 25, 2017 | Vortran Medical Technology 1, Inc VORTRAN Automatic Resuscitator, VARPlus;
Model PTE-5002; Qty: 10 each
Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure Terminated |
BTL | K001430 K041473 +1 |
| Jan 11, 2016 | Thornhill Research Inc MOVES System Lithium Polymer Batteries
The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilator Terminated |
BTL | K093261 |
| Jan 11, 2016 | Thornhill Research Inc MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities.
The MOVES System is a portable computer controlled electrically powered tr Terminated |
BTL | K093261 |
| Oct 22, 2015 | Mercury Enterprises, Inc. dba Mercury Medical Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit.
The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of Terminated |
BTL | K093913 |
| Apr 10, 2014 | Draeger Medical Systems, Inc. Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 Terminated |
BTL | K103625 |
| Feb 25, 2014 | GE Healthcare, LLC GE Healthcare - Giraffe and Panda iRes Infant Warmer
Product Usage:
The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on the Terminated |
BTL | K070377 K090697 +2 |
| Feb 25, 2014 | GE Healthcare, LLC GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System.
Product Usage:
The T-Piece Resuscitation System [ventilator, emergency powered resusci Terminated |
BTL | K070210 |
| Feb 3, 2014 | GE Healthcare Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com***
Provides the basic equ Terminated |
BTL | K070210 |
| Feb 3, 2014 | GE Healthcare Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M12414 Terminated |
BTL | K070210 |
| Apr 16, 2013 | Instrumentation Industries Inc Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/I Terminated |
BTL | K991785 |
| Feb 8, 2013 | GE Healthcare, LLC GE Healthcare - Giraffe and Panda T-Piece Resuscitation System
The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic Terminated |
BTL | K070210 |
| Dec 26, 2012 | GE Healthcare, LLC GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece D Terminated |
BTL | K070210 |
| Nov 4, 2011 | Impact Instrumentation, Inc. Model 73X Uni-Vent
Product Usage: Intended for use at mass casualty incidents. Terminated |
BTL | K051476 |
| Jul 4, 2007 | Smiths Medical PM, Inc. Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, p Terminated |
BTL | K051322 |
| Jan 24, 2006 | Smiths Medical PM, Inc. Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of p Terminated |
BTL | None listed |
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