FDA.reportPublic FDA data

Percussionaire

Primary DI
00849436000600
Brand
Percussionaire
Company
PERCUSSIONAIRE CORPORATION
Model
TXP5
Catalog number
TXP5
Device description
TXP5 Ventilator, English, DISS Inlet
Published
2020-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849436000607PackageGS11Not in Commercial Distribution
00849436000600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084943600060710849436000607
00849436000600008494360006008494360006000849436000600

GMDN Terms#

Term, Definition table
TermDefinition
Portable pneumatic ventilatorA 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).

Contacts#

Phone, Email table
PhoneEmail
208-263-2549customerservice@percussionaire.com

Regulatory Flags#

DUNS number
603048778
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849436000143PercussionaireF00001-C-FRS00002-C-FR2016-09-27
00849436000174PercussionaireF00007-BS00015-B2015-10-21
00849436000730PercussionaireF00002-CS00003-C-ES2024-08-05
00849436000549PercussionaireF00002-CS00003-C-EU12018-09-20
00849436000655PercussionaireF00002-C-FRS00003-C-FR12021-06-10
00849436000662PercussionaireF00007-1S00015-22024-01-09
00849436000020PercussionaireF00001-CS00002-C2015-10-21
00849436000037PercussionaireF00002-CS00003-C2015-10-21
00849436000044PercussionaireF00008-1S00018-12015-10-21
00849436000068PercussionaireF00007-1S00015-12015-10-21
00849436000679PercussionaireIPV1S000652023-06-21
00849436000235PercussionaireF00038-2S00033-22015-10-21
00849436000471PercussionaireF00038-2FRS00033-2FR2016-07-25
00849436000242PercussionaireTravel AirS000552017-06-13
10849436000737PercussionaireF00002-CS00003-C-ES2024-08-05
00849436000723PercussionaireP5-TEEP5-TEE2024-07-22
10849436000720PercussionaireP5-TEEP5-TEE2024-07-22
00849436000709PercussionaireIPV1S00065-EU2024-06-27
00849436000716PercussionaireIPV1S00065-FR2024-06-27
10849436000706PercussionaireIPV1S00065-EU2024-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
10889483604045AirLife™AIRLIFECBK2025-02-26
10889483604052AirLife™AIRLIFECBK2025-02-26
10889483604069AirLife™AIRLIFECBK2025-02-26
10889483604076AirLife™AIRLIFECBK2025-02-26
10889483604083AirLife™AIRLIFECBK2025-02-26
10889483604090AirLife™AIRLIFECBK2025-02-26