Identity
- Trade Name
- CPS™ FDA UDI
- Generic Name
- Intravascular catheter slitter FDA UDI
- Device Name
- Universal Slitter FDA UDI
- Model / Reference
- DS2A003 FDA UDI
- Description
- Universal Slitter FDA UDI
Identifiers
- Catalog Number
- DS2A003 FDA UDI
- Primary DI / UDI-DI
- 05414734218320 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Intravascular catheter slitter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
MR Unsafe FDA UDI
Category: Intravascular catheter slitter
Cps™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular catheter slitter.
- ScoutPro Slitter Tool Advanced — BIOTRONIK SE & Co. KG · Class II
- Worley™ Slitter — Merit Medical Systems, Inc. · Class I
- ACUITY™ — Boston Scientific · Class II
- Worley™ Slitter — Merit Medical · Class I
- CPS™ — ST. JUDE MEDICAL, INC. · Class I
- CPS 3D Plus — ST. JUDE MEDICAL, INC. · Class I
- Agilis HisPro™ — ST. JUDE MEDICAL, INC. · Class I
- CPS™ — ST. JUDE MEDICAL, INC. · Class II
Cleared under the same submission
K092075 also covers:
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
K103250 also covers:
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — ST. JUDE MEDICAL, INC.
- CPS DIRECT™ — 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 4f452ec1-a8a1-4e14-94be-bb65f9f5e1d3 37 fields · synced May 30, 2026