FDA.reportPublic FDA data

Percussionaire

Primary DI
00849436000259
Brand
Percussionaire
Company
PERCUSSIONAIRE CORPORATION
Model
A50094-D
Catalog number
A50094-D
Device description
Phasitron Kit, VDR, Single Patient
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10849436000256PackageGS15In Commercial Distribution
00849436000259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084943600025610849436000256
00849436000259008494360002598494360002590849436000259

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
603048778
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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

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