Identity
- Trade Name
- DLP® FDA UDI
- Generic Name
- Invasive blood pressure monitoring tubing set FDA UDI
- Device Name
- PCP SET 50010 3FR - 17GA 10PK 17L FDA UDI
- Model / Reference
- 50010 FDA UDI
- Description
- PCP SET 50010 3FR - 17GA 10PK 17L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20613994654056 FDA UDI
- 510(k) Number
- K841482 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Invasive blood pressure monitoring tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 3.0 French FDA UDI
Category: Invasive blood pressure monitoring tubing set
Dlp® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K841482 also covers:
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
- Medtronic, Inc.
Sources (1)
- FDA UDI a12ac1e8-5b49-4fe8-998a-720758ff49c5 36 fields · synced May 30, 2026