FDA UDI
In Commercial Distribution
🇺🇸 United States
Soft-Vu
DI: H787107338010
·
Model: 10733801
·
ANGIODYNAMICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Soft-Vu
- Primary DI
- H787107338010
- Version / Model
- 10733801
- Company Name
- ANGIODYNAMICS, INC.
- Labeler DUNS
- 079105071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 4
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- d110ded0-fbb1-430d-944a-c64c2b8f1809
Device Description
Soft-Vu Angiographic Catheter, Kerns, Non-Braided
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 |
|---|---|---|---|---|
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10688 | Angiographic catheter, single-use | A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H787107338015 | HIBCC | BOX | 5 | In Commercial Distribution | |
| Primary | H787107338010 | HIBCC | ||||
| Secondary | 15051684009966 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 4 | French | |
| Length | 65 | Centimeter | |
| Outer Diameter | 1.4 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 27 Degrees Celsius