Identity
- Trade Name
- AKITA JET FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume control to ensure precise drug dosing and targeting. It is intended only on conscious, cooperative adults and children with severe asthma. It is designed for temporary oral inhalation of the aerosol created by the device. The system is intended for single patient use. FDA UDI
- Model / Reference
- AKITA JET Inhalation System FDA UDI
- Description
- The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume control to ensure precise drug dosing and targeting. It is intended only on conscious, cooperative adults and children with severe asthma. It is designed for temporary oral inhalation of the aerosol created by the device. The system is intended for single patient use. FDA UDI
Identifiers
- Catalog Number
- 01RS0100 FDA UDI
- Primary DI / UDI-DI
- 05056143200154 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Akita Jet by Vectura Group Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Vectura Group Plc
Sources (1)
- FDA UDI 700746d9-f0ba-4aee-8625-5aa8e08aae7b 37 fields · synced Jun 6, 2026