Identity
- Trade Name
- Vital Sync FDA UDI
- Generic Name
- Multiparameter physiologic analysis workstation FDA UDI
- Device Name
- VITAL SYNC V4 SOFTWARE FDA UDI
- Model / Reference
- VITALSYNCSW04 FDA UDI
- Description
- VITAL SYNC V4 SOFTWARE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521854260 FDA UDI
- 510(k) Number
- K160718 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Multiparameter physiologic analysis workstation 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: Multiparameter physiologic analysis workstation
Vital Sync by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiparameter physiologic analysis workstation.
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- TFC Fingersensor 150 MEDIUM — CNSystems Medizintechnik GmbH · Class II
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- CorVista® System with PH Add-On — Analytics For Life, 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 5d343f9e-3805-46d6-849d-8c2e136e8802 35 fields · synced May 30, 2026