Identity
- Trade Name
- Guardian® II NC hemostasis valve FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional procedures. FDA UDI
- Model / Reference
- 8215 FDA UDI
- Description
- The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20682150 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Guardian® II NC hemostasis valve by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI 2b46ddbf-5fc2-47c5-8775-a1ab59959fa4 35 fields · synced May 30, 2026