Echo-Screen Hearing Screening Supplies

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name: Echo-Screen Hearing Screening Supplies FDA UDI
Generic Name: Ear simulator, acoustic coupler FDA UDI
Device Name: 25 sets of Echo-Screen II Ear Couplers and 25 sets of Snap Electrodes. FDA UDI
Model / Reference: Echo-PAK FDA UDI
Description: 25 sets of Echo-Screen II Ear Couplers and 25 sets of Snap Electrodes. FDA UDI

Identifiers

Catalog Number: 1630-25-US FDA UDI
Primary DI / UDI-DI: 00382830051231 FDA UDI
510(k) Number: K013977 FDA UDI
FDA Product Code: GWJ FDA UDI
GMDN Term: Ear simulator, acoustic coupler FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1900 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

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

FDA UDI

Category: Analytical scalp electrode, single-use Ear simulator, acoustic coupler

Echo-Screen Hearing Screening Supplies by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K013977 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: Natus Medical Incorporated

Sources (1)

FDA UDI 7cab5d27-03b0-43ec-8940-746a25afd6c1 36 fields · synced May 30, 2026