FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vasc Band™ hemostat
DI: M20635240
·
Model: 3524
·
Vascular Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vasc Band™ hemostat
- Primary DI
- M20635240
- Version / Model
- 3524
- 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
- 2023-06-06
- Public Version Status
- Update
- Public Device Record Key
- 012fac6f-09a7-4dd5-9483-85fd7496e112
- Distribution End Date
- 2020-07-05
Device Description
The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
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 |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58704 | Radial artery compression device | A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M20635241 | HIBCC | Box | 10 | Not in Commercial Distribution | 2020-07-05 |
| Primary | M20635240 | HIBCC |
Customer Contacts
- Phone
- 888-240-6001
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Centimeter |