vMap Control Unit

FDA UDI

Class II (US FDA UDI)

by Vektor Medical, Inc.

Identity

Trade Name: vMap Control Unit FDA UDI
Generic Name: Cardiac mapping system computer FDA UDI
Model / Reference: VMCU1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007954177 FDA UDI
510(k) Number: K211546 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Cardiac mapping system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac mapping system computer

vMap Control Unit by Vektor Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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GEMS Win Air — CardioComm Solutions, Inc · Class II

Cleared under the same submission

K211546 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: Vektor Medical, Inc.

Sources (1)

FDA UDI b0d0ed54-004a-4a53-b599-acb3154fc1a7 33 fields · synced May 30, 2026