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Natus Medical

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name
NATUS MEDICAL FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
Echo-Screen III Pro Hearing Screening Device ABR set w/o Barcode Scanner FDA UDI
Model / Reference
013512 FDA UDI
Description
Echo-Screen III Pro Hearing Screening Device ABR set w/o Barcode Scanner FDA UDI

Identifiers

Primary DI / UDI-DI
00382830044585 FDA UDI
510(k) Number
K141446 FDA UDI
FDA Product Code
GWJ FDA UDI
GMDN Term
Evoked-potential audiometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1900 FDA UDI
Commercial Distribution
Not 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

No

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

Yes

FDA UDI

Natus Medical by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141446 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Incorporated

Sources (1)

  • FDA UDI 1540f7ff-1a34-440a-8859-40bbbddca539 36 fields · synced May 31, 2026