FDA UDI
In Commercial Distribution
🇺🇸 United States
ENVI
DI: H965355110
·
Model: 35-510
·
NAVILYST MEDICAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ENVI
- Primary DI
- H965355110
- Version / Model
- 35-510
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-07
- Public Version
- 6
- Public Version Date
- 2021-08-12
- Public Version Status
- Update
- Public Device Record Key
- 30065673-f29a-48fd-abc2-8a0216c037d6
Device Description
NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GBX | CATHETER, IRRIGATION | General, Plastic Surgery | 878.4200 | 1 |
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H965355110 | HIBCC | ||||
| Package | H965355111 | HIBCC | BOX | 5 | In Commercial Distribution | |
| Secondary | 15051684023641 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170775 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 0.5 | Millimeter | |
| Needle Gauge | 21 | Gauge | |
| Length | 20 | Centimeter | |
| Catheter Gauge | 6 | French |