FDA.reportPublic FDA data

Percussionaire

Primary DI
00849436000327
Brand
Percussionaire
Company
PERCUSSIONAIRE CORPORATION
Model
A50474-2D
Catalog number
A50474-2D
Device description
Phasitron Kit, IPV/CMV, Single Patient
Published
2015-10-21
Public version status
Update
Distribution status
Not 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
NHJDevice, Positive Pressure Breathing, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905236000IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIESPercussionaire Corp.1991-04-18NHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849436000324PackageGS15Not in Commercial Distribution
00849436000327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084943600032410849436000324
00849436000327008494360003278494360003270849436000327

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
08500501360228BiWaze Clear Dual Lumen Circuit With Face Mask - InfantAbmrc LLCNHJ2026-05-20
08500501360235BiWaze Clear Dual Lumen Circuit - AcuteAbmrc LLCNHJ2026-05-20
00887761008038The Vest APX SystemHILL-ROM SERVICES PTE. LTD.NHJ2026-03-18
00887761008045The Vest APX SystemHILL-ROM SERVICES PTE. LTD.NHJ2026-03-18
07321822320002ClearoBreas Medical ABNHJ2026-02-17
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-12-02
07321820104666Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
05060405720083ClearoBreas Medical ABNHJ2025-11-03
07321820081691ClearoBreas Medical ABNHJ2025-11-03
07321820082834ClearoBreas Medical ABNHJ2025-11-03
07321820090655ClearoBreas Medical ABNHJ2025-11-03
07321820090662ClearoBreas Medical ABNHJ2025-11-03
07321820090679ClearoBreas Medical ABNHJ2025-11-03
07321820106226Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-08-06
08809517011064Comfort CoughSeoil Pacific Corp.NHJ2025-02-19
00850018761383VOCSN Passive ValveVentec Life Systems, Inc.NHJ2024-12-02
00849436000730PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
10849436000737PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
00849436000709PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
00849436000716PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000706PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000713PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
08500501360013BiWaze Cough Dual Lumen Circuit With MouthpieceAbmrc LLCNHJ2024-04-01
08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterAbmrc LLCNHJ2024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildAbmrc LLCNHJ2024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCNHJ2024-04-01
08500501360051BiWaze Cough Dual Lumen Circuit With Face Mask - Adult MediumAbmrc LLCNHJ2024-04-01
08500501360068BiWaze Cough Dual Lumen Circuit With Face Mask - Adult LargeAbmrc LLCNHJ2024-04-01
00887761981690Volara SystemHILL-ROM SERVICES PTE. LTD.NHJ2023-11-28