Identity
- Trade Name
- SmartLinx Vitals Plus FDA UDI
- Generic Name
- Patient monitoring system module, interfacing FDA UDI
- Device Name
- VitalsPlus NiBP Suntech Oximeter Masimo with RollStand FDA UDI
- Model / Reference
- SL-VP-BPAP-HW FDA UDI
- Description
- VitalsPlus NiBP Suntech Oximeter Masimo with RollStand FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615040000117 FDA UDI
- 510(k) Number
- K151071 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Patient monitoring system module, interfacing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, interfacing
SmartLinx Vitals Plus by Philips North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient monitoring system module, interfacing.
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Cleared under the same submission
K151071 also covers:
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
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
- Philips North America LLC
Sources (1)
- FDA UDI 9a8b87b7-14ab-46b2-9cda-9812dd0d83fb 34 fields · synced Jun 8, 2026