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Ics

FDA UDI

Class I (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name
ICS FDA UDI
Generic Name
Diagnostic caloric vestibular stimulation system FDA UDI
Device Name
AirCal Caloric Stimulator, Extended (Extended length - 4m) FDA UDI
Model / Reference
8-04-13320 FDA UDI
Description
AirCal Caloric Stimulator, Extended (Extended length - 4m) FDA UDI

Identifiers

Primary DI / UDI-DI
05713315009259 FDA UDI
FDA Product Code
KHH FDA UDI
GMDN Term
Diagnostic caloric vestibular stimulation system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.1800 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic caloric vestibular stimulation system

Ics by Natus Medical Denmark ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic caloric vestibular stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Denmark ApS

Sources (1)

  • FDA UDI 70f145ae-1758-424c-a313-ad98619bcf45 33 fields · synced May 30, 2026