FDA.reportPublic FDA data

Percussionaire

Primary DI
00849436000471
Brand
Percussionaire
Company
PERCUSSIONAIRE CORPORATION
Model
F00038-2FR
Catalog number
S00033-2FR
Device description
Sinusoidal Bronchotron and Universal Monitron Transport, French.
Published
2016-07-25
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905235000VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESSPercussionaire Corp.1991-05-03CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849436000471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849436000471008494360004718494360004710849436000471

GMDN Terms#

Term, Definition table
TermDefinition
Transport pneumatic high-frequency ventilatorA pneumatically-powered automatic cycling machine intended to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is used to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space (percussive ventilation). It is typically a compact, lightweight, rugged device powered either by institutional gas supply or on-board compressor systems, with manually-operated user interface. It is used in conjunction with an endotracheal (ET) tube, tracheostomy cannula, or mask.

Sterilization Methods#

Method table
Method

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
00849436000600PercussionaireTXP5TXP52020-04-01
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
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
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