Identity
- Trade Name
- AirGent-2.0 FDA UDI
- Generic Name
- Needleless medication/vaccine injector, pneumatic FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- AA FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017151007 FDA UDI
- 510(k) Number
- K082138 FDA UDI
- FDA Product Code
- KZE FDA UDI
- GMDN Term
- Needleless medication/vaccine injector, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Needleless medication/vaccine injector, pneumatic
AirGent-2.0 by Perfaction Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needleless medication/vaccine injector, pneumatic.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Perfaction Technologies Ltd
Sources (1)
- FDA UDI fdfef7cb-4e5a-4a0b-97ce-9831128ad43e 34 fields · synced May 30, 2026