FDA UDI
In Commercial Distribution
🇺🇸 United States
Treatment Kit 2.0
DI: 07290016746754
·
Model: GM00030 (US)
·
VIORA LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Treatment Kit 2.0
- Primary DI
- 07290016746754
- Version / Model
- GM00030 (US)
- Catalog Number
- GM00030 (US)
- Company Name
- VIORA LTD
- Labeler DUNS
- 514612758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-03
- Public Version
- 3
- Public Version Date
- 2025-09-09
- Public Version Status
- Update
- Public Device Record Key
- e9468adf-9f03-4529-8c22-df6eea09d845
Device Description
EnerJet Treatment Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 07290016746761 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 07290016746754 | GS1 |
Customer Contacts
- Phone
- 888 415 1192
- [email protected]