NovaKit™ 2 Exam Pack

FDA UDI

Class II (US FDA UDI)

by Novasignal Corporation

Identity

Trade Name: NovaKit™ 2 Exam Pack FDA UDI
Generic Name: Noninvasive vascular ultrasound support kit FDA UDI
Model / Reference: 25-00004 FDA UDI

Identifiers

Catalog Number: NSC-NVK FDA UDI
Primary DI / UDI-DI: 00850681007283 FDA UDI
510(k) Number: K213279 FDA UDI
FDA Product Code: IYN FDA UDI
ITX FDA UDI
GMDN Term: Noninvasive vascular ultrasound support kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Noninvasive vascular ultrasound support kit

NovaKit™ 2 Exam Pack by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound support kit.

NovaKit Exam Pack (NovaKit) — Novasignal Corporation · Class II
Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack — Novasignal Corporation · Class II

Cleared under the same submission

K213279 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: Novasignal Corporation

Sources (1)

FDA UDI 65b98a97-0f8d-4ada-b17c-09096beb78af 34 fields · synced Jun 8, 2026