Natus

Primary DI
00382830054331
Brand
Natus
Company
NATUS MEDICAL INCORPORATED
Model
Child/Adult Ear Tip 7 mm
Catalog number
1913-US
Device description
Child/Adult Ear Tip, White, size 7 mm, Qty 50
Published
2017-06-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013977000ECHO-SCREEN T, TA, TD, TDA, TCFischer-Zoth Audiologic Systems, Inc.2002-06-14GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830054331PrimaryGS10
00382830054683Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830054331003828300543313828300543310382830054331
00382830054683003828300546833828300546830382830054683

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric ear tipA non-sterile luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Millimeter
Lumen/Inner Diameter2.9Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-303-0306Technical_service@natus.com

Regulatory Flags#

DUNS number
962519208
Device count
50
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00382830045292Echo-Screen III ProEchoScreen III Refurbished, ABR with barcode023482R2020-02-20
00382830045315Echo-Screen III ProEchoScreen III Refurbished, TEOAE & DPOAE with bar023483R2020-02-20
00382830045339Echo-Screen III ProEchoScreen III Refurbished, TEOAE & ABR with barco023484R2020-02-20
00382830045353Echo-Screen III ProEchoScreen III Refurbished, DPOAE & ABR with barco023485R2020-02-20
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00382830000741Bio-logicOAE Foam Tip Adult203202, 294272017-03-31
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00382830000819Bio-logicOAE Tree Tip203218, 294222017-03-31
00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
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