FDA UDI
In Commercial Distribution
🇺🇸 United States
VWING Vascular Needle Guide
DI: 08199260101472
·
Model: 00147
·
VITAL ACCESS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VWING Vascular Needle Guide
- Primary DI
- 08199260101472
- Version / Model
- 00147
- Catalog Number
- 00147
- Company Name
- VITAL ACCESS CORPORATION
- Labeler DUNS
- 180346285
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-02-04
- Public Version
- 4
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 51b6cb84-9003-4dbf-a76d-218735807e4c
Device Description
VWING Vascular Needle Guide 6mm x 9mm
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| PFH | Venous Window Needle Guide | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58816 | Arteriovenous fistula buttonhole cannulation guide | A metal implant intended to be attached (sutured) to, or placed above, an arteriovenous fistula (AVF) under the skin to act as a guide when using a constant site (buttonhole) method of blunt needle insertion. It is typically used during haemodialysis procedures where the device can be palpated (felt) beneath the skin and the cannulation directed into the device where it will funnel the needle point towards a constant entry site in the vessel wall. It is typically made of titanium (Ti) and is available in a range of sizes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08199260101472 | GS1 |
Customer Contacts
- Phone
- (801)433-9390
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18 | Millimeter | |
| Width | 9 | Millimeter | |
| Height | 6 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from heat. Store in a dry place at room temperature.