Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Model / Reference
- 405512 FDA UDI
Identifiers
- Catalog Number
- 405512 FDA UDI
- Primary DI / UDI-DI
- 05414734053716 FDA UDI
- 510(k) Number
- K894330 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular dilator, single-use 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDILength — 19 Centimeter FDA UDI
Category: Vascular dilator, single-use
Sjm™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular dilator, single-use.
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- Prelude® — Merit Medical Systems, Inc. · Class II
- Prelude EASE™ — Merit Medical Systems, Inc. · Class II
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- Merit PAK™ — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K894330 also covers:
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE 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
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI b1410570-560d-4411-8c8a-5a38a6dca161 37 fields · synced Jun 6, 2026