Identity
- Trade Name
- Treatment Kit 2.0 FDA UDI
- Generic Name
- Needleless medication/vaccine injector, pneumatic FDA UDI
- Device Name
- EnerJet Treatment Kit FDA UDI
- Model / Reference
- GM00030 (US) FDA UDI
- Description
- EnerJet Treatment Kit FDA UDI
Identifiers
- Catalog Number
- GM00030 (US) FDA UDI
- Primary DI / UDI-DI
- 07290016746754 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needleless medication/vaccine injector, pneumatic
Treatment Kit 2.0 by Viora 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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- Disposable Delivery Nozzle — VIORA LTD · Class II
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
- Viora Ltd
Sources (1)
- FDA UDI e9468adf-9f03-4529-8c22-df6eea09d845 35 fields · synced Jun 8, 2026