FDA.reportPublic FDA data

Percussionaire

Primary DI
10849436000577
Brand
Percussionaire
Company
PERCUSSIONAIRE CORPORATION
Model
F00001-C
Catalog number
S00002-C-EU1
Device description
IPV1C, English, European Multimeter, Dual Gas, NIST-Air, DISS-Oxy
Published
2019-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10849436000577PackageGS11In Commercial Distribution
00849436000570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084943600057710849436000577
00849436000570008494360005708494360005700849436000570

GMDN Terms#

Term, Definition table
TermDefinition
Portable pneumatic high-frequency ventilatorA pneumatically-powered device designed to be easily moved/mounted and intended to provide long-term support or therapeutic alveolar ventilation for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs using a frequency that is considerably higher than physiological breathing rates and a tidal volume less than or equal to the anatomic dead space (percussive ventilation), typically through an endotracheal (ET) tube, tracheostomy cannula, or mask. It typically includes a control system and alarms, sometimes with additional features (e.g., humidification).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
603048778
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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