Home GUDID 00813841020874 Bio-Med Devices, Inc.
Primary DI 00813841020874
Brand Bio-Med Devices, Inc.
Company BIO-MED DEVICES, INC.
Model IC-2A
Catalog number 8001AMRI
Device description Adult Ventilator, pneumatic
Published 2015-11-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true Product Codes# Code, Name table Code Name CBK Ventilator, Continuous, Facility Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CBK Ventilator, Continuous, Facility Use Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813841020874 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813841020874 00813841020874 813841020874 0813841020874
GMDN Terms# Term, Definition table Term Definition Portable pneumatic ventilator A pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS).
Regulatory Flags# DUNS number 116167966 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00813841020027 Bio-Med Devices, Inc. TV-100 5500 2024-12-31 00813841022281 Bio-Med Devices, Inc. 10300 10300 2023-06-12 00813841022298 Bio-Med Devices, Inc. 10301 10301 2023-06-12 00813841022304 Bio-Med Devices, Inc. 2003TR 2003TR 2023-06-12 00813841021260 Bio-Med Devices, Inc. 2003P 2003P 2019-10-04 00813841021277 Bio-Med Devices, Inc. 2003Q 2003Q 2019-10-04 00813841021307 Bio-Med Devices, Inc. 2003U 2003U 2019-10-04 00813841021567 Bio-Med Devices, Inc. 2001C 2001C 2019-10-04 00813841021574 Bio-Med Devices, Inc. 2003FFE1A 2003FFE1A 2019-10-04 00813841021581 Bio-Med Devices, Inc. 2003FFEUA 2003FFEUA 2019-10-04 00813841021611 Bio-Med Devices, Inc. 20011PE 20011PE 2019-10-04 00813841021628 Bio-Med Devices, Inc. 40011PE 40011PE 2019-10-04 00813841021635 Bio-Med Devices, Inc. 80018PE 80018PE 2019-10-04 00813841021642 Bio-Med Devices, Inc. 20011NPE 20011NPE 2019-10-04 00813841020010 Bio-Med Devices, Inc. 2003GE 2003GE 2015-11-02 00813841020034 Bio-Med Devices, Inc. 2001 2001 2015-11-02 00813841020041 Bio-Med Devices, Inc. 2002 2002 2015-11-02 00813841020058 Bio-Med Devices, Inc. 2003 2003 2015-11-02 00813841020065 Bio-Med Devices, Inc. 2004 2004 2015-11-02 00813841020072 Bio-Med Devices, Inc. 2000K 2000K 2015-11-02
Other Devices Sharing Product Codes# 
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