FDA UDI
In Commercial Distribution
🇺🇸 United States
Soft-Vu
DI: H787107100540
·
Model: 10710054
·
ANGIODYNAMICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Soft-Vu
- Primary DI
- H787107100540
- Version / Model
- 10710054
- Company Name
- ANGIODYNAMICS, INC.
- Labeler DUNS
- 079105071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-29
- Public Version
- 2
- Public Version Date
- 2019-07-15
- Public Version Status
- Update
- Public Device Record Key
- f730513d-ad1f-43ca-9afb-3643eb27ba6e
Device Description
Soft-Vu Angiographic Catheter, Sidewinder 1 ST, 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 |
|---|---|---|---|---|---|---|
| Secondary | 15051684015752 | GS1 | ||||
| Primary | H787107100540 | HIBCC | ||||
| Package | H787107100545 | HIBCC | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173762 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French | |
| Outer Diameter | 1.8 | Millimeter | |
| Length | 65 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 27 Degrees Celsius