Identity
- Trade Name
- MiniSPC Button FDA UDI
- Generic Name
- Suprapubic drainage catheter FDA UDI
- Device Name
- 14F x 2.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set FDA UDI
- Model / Reference
- SPC-1425-24 FDA UDI
- Description
- 14F x 2.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set FDA UDI
Identifiers
- Catalog Number
- SPC-1425-24 FDA UDI
- Primary DI / UDI-DI
- 00842071147488 FDA UDI
- 510(k) Number
- K240514 FDA UDI
- FDA Product Code
- KOB FDA UDIKNT FDA UDI
- GMDN Term
- Suprapubic drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5090 FDA UDI876.5980 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDILength — 2.5 Centimeter FDA UDI
Category: Suprapubic drainage catheter
MiniSPC Button by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suprapubic drainage catheter.
- Bardex® Pezzer Model Drain — C. R. Bard, Inc. · Class II
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- RUSCH — TELEFLEX INCORPORATED · Class II
- Bardex® Angle Drain Four-Wing Malecot Type — C. R. Bard, Inc. · Class II
- Bardex® Pezzer Model Drain — C. R. Bard, Inc. · Class II
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
Cleared under the same submission
K240514 also covers:
- AMT MiniSPC Drainage Set — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, Inc.
- MiniSPC Button — Applied Medical Technology, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI 54a8ec37-c8cf-4bbb-b1b5-fc5ef0a827c8 37 fields · synced Jun 9, 2026