Identity
- Trade Name
- Elite HV® FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- 4FR X 12CM X 035 HEMO INTRODUCER SET FDA UDI
- Model / Reference
- 612806 FDA UDI
- Description
- 4FR X 12CM X 035 HEMO INTRODUCER SET FDA UDI
Identifiers
- Catalog Number
- 612806 FDA UDI
- Primary DI / UDI-DI
- 04046964347597 FDA UDI
- 510(k) Number
- K043525 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- 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
Category: Vascular catheter introduction set, nonimplantable
Elite HV® by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K043525 also covers:
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Radial Micro-HV Introducer Kit — Galt Medical Corp.
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
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI aae15a3c-5ae2-4c08-a99b-6bf6b1f4cb89 37 fields · synced May 30, 2026