FDA UDI
In Commercial Distribution
🇺🇸 United States
AirGent-2.0
DI: 07290017151007
·
Model: AA
·
PERFACTION TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AirGent-2.0
- Primary DI
- 07290017151007
- Version / Model
- AA
- Company Name
- PERFACTION TECHNOLOGIES LTD
- Labeler DUNS
- 514595888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-18
- Public Version
- 1
- Public Version Date
- 2019-01-18
- Public Version Status
- New
- Public Device Record Key
- fdfef7cb-4e5a-4a0b-97ce-9831128ad43e
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KZE | Injector, Fluid, Non-Electrically Powered | General Hospital | 880.5430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42949 | Needleless medication/vaccine injector, pneumatic | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017151007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082138 | 000 |