AirGent-2.0

Primary DI
07290017151007
Brand
AirGent-2.0
Company
PERFACTION TECHNOLOGIES LTD
Model
AA
Device description
The AirGent-2.0 system is a pneumatically powered system that features a safe, minimally-invasive platform for uniformed administration of therapeutic compound into the dermis. The Enerjet2.0 is a needle-free injection system that generates a high velocity jet of fluid that penetrates the skin.
Published
2018-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZEInjector, Fluid, Non-Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZEInjector, Fluid, Non-Electrically PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082138000AIRGENT, MODEL AG7000010Perfaction, Inc.2009-01-23KZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017151007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017151007072900171510077290017151007

GMDN Terms#

Term, Definition table
TermDefinition
Needleless medication/vaccine injector, pneumaticA hand-held, pneumatically-powered device designed to inject medication (especially a local anaesthetic) or vaccine transcutaneously into the human body. It is needleless and may have various configurations according to its application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure by compressed gas. The delivered medication/vaccine will typically be supplied in prefilled containers that are loaded into the device. This is not a hypodermic syringe. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514595888
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284222250Robbins Dermo-jetRobbins Instruments Inc.KZE2025-08-22
07290016746754Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746761Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746716ConsoleVIORA LTDKZE2025-05-22
07290016746723ApplicatorVIORA LTDKZE2025-05-22
07290016746730TrolleyVIORA LTDKZE2025-05-22
07290016746747Disposable Delivery NozzleVIORA LTDKZE2025-05-22
B07281641001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
B07281642001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
07640180261018ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
07640180261001ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
00856457003329Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003336Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003206Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003213Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003305Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003312Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003367Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003374Stratis®PHARMAJET, INC.KZE2016-09-19