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Sensis Vibe Combo

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name
Sensis Vibe Combo FDA UDI
Generic Name
Cardiac catheterization laboratory computer FDA UDI
Device Name
Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22 FDA UDI
Model / Reference
11007642 FDA UDI
Description
Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22 FDA UDI

Identifiers

Primary DI / UDI-DI
04056869010205 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac catheterization laboratory computer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

No

FDA UDI

Category: Cardiac catheterization laboratory computer

Sensis Vibe Combo by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac catheterization laboratory computer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare

Sources (1)

  • FDA UDI 392a1813-589b-42a4-9b17-73d007565949 35 fields · synced May 30, 2026