Identity
- Trade Name
- Vital Sync FDA UDI
- Generic Name
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
- Device Name
- Vital Sync Mobile Application Software FDA UDI
- Model / Reference
- VSMOBILEAPPSW01 FDA UDI
- Description
- Vital Sync Mobile Application Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521815810 FDA UDI
- 510(k) Number
- K160718 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wireless patient monitor/sensor reporting software, layperson-use
Vital Sync by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wireless patient monitor/sensor reporting software, layperson-use.
- TempTraq® — Blue Spark Technologies, Inc. · Class II
- OPSB Sensor Web Portal — Boston Brace International, Inc. · Class I
- SMART TSF — Smith & Nephew, Inc. · Class II
- Orpyx SI Sensory Insoles — Orpyx · Class II
- OPSB Sensor Cloud Backend — Boston Brace International, Inc. · Class I
- OPSB Sensor — Boston Brace International, Inc. · Class I
- OPSB Sensor Mobile App — Boston Brace International, Inc. · Class I
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K160718 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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI cd38050d-1801-4f73-825e-e6af41b577c4 35 fields · synced May 31, 2026