Identity
- Trade Name
- Vaxcel FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Vaxcel Mini Stick Kit Coaxial Dilator Set FDA UDI
- Model / Reference
- 45992 FDA UDI
- Description
- Vaxcel Mini Stick Kit Coaxial Dilator Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- M001459920 FDA UDI
- 510(k) Number
- K974640 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 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
No
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
Dimensions & Sizes
- Size
- Catheter Gauge — 4 French FDA UDIOuter Diameter — 1.7 Millimeter FDA UDILength — 9.4 Centimeter FDA UDINeedle Gauge — 21 Gauge FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Vaxcel by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K974640 also covers:
- Vaxcel Mini Stick — ANGIODYNAMICS, INC
- Vaxcel Mini Stick — ANGIODYNAMICS, INC
- Vaxcel Mini Stick — ANGIODYNAMICS, INC
- Vaxcel Mini Stick — ANGIODYNAMICS, INC
- Vaxcel Mini Stick — ANGIODYNAMICS, INC
- Vaxcel Mini Stick — ANGIODYNAMICS, INC.
- Vaxcel Mini Stick — ANGIODYNAMICS, INC.
- Vaxcel — NAVILYST MEDICAL, INC.
- Vaxcel — NAVILYST MEDICAL, INC.
- Vaxcel — NAVILYST MEDICAL, INC.
- Vaxcel — NAVILYST MEDICAL, INC.
- Vaxcel — NAVILYST MEDICAL, INC.
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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI 80d032bc-970b-4998-83b1-48887ef375b7 36 fields · synced May 30, 2026