FDA.reportPublic FDA data

Percussionaire

Primary DI
10849436000256
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
OTC
false
Sterile
false
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. 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 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.

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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