FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Angio Assist™ docking station
DI: M20681510
·
Model: 8151
·
Vascular Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Angio Assist™ docking station
- Primary DI
- M20681510
- Version / Model
- 8151
- Company Name
- Vascular Solutions, Inc.
- Labeler DUNS
- 008999906
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 4
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- f271608a-8316-4420-a680-5fbc1b556b30
- Distribution End Date
- 2021-02-28
Device Description
The AngioAssist Docking Station is intended to stabilize and load guidewires and catheters during percutaneous procedures.
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
- Yes
- 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 |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35954 | Medical device rail | A device in the form of a narrow bar designed to be fixed on the wall for mounting and organizing medical devices [e.g., in hospital wards, treatment rooms, intensive care units (ICU)]; the equipment to be supported is not included. It may be used in conjunction with clamps and/or poles. It is available in various lengths. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M20681511 | HIBCC | Box | 16 | Not in Commercial Distribution | 2021-02-28 |
| Primary | M20681510 | HIBCC |