FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094185584
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
39422-47-025
Device description
Welch Allyn Single Use Ear Tip for OAE Hearing Screener; 4-7 mm Flanged; Qty. 25
Published
2020-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTPTympanometer, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTPTympanometer, ExemptEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094185584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094185584007320941855847320941855840732094185584

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22
00732094322927Welch Allyn, Inc.901134ESCRIBE-BEX-CXACA2019-07-22
00732094322934Welch Allyn, Inc.901134ESCRIBE-BEX-CXAAA2019-07-22
00732094322941Welch Allyn, Inc.901134ESCRIBE-BAX-DXACX2019-07-22
00732094322958Welch Allyn, Inc.901134ESCRIBE-BAX-DXACB2019-07-22
00732094322965Welch Allyn, Inc.901134ESCRIBE-BAX-CXXXX2019-07-22
00732094322972Welch Allyn, Inc.901134ESCRIBE-BAX-CXACB2019-07-22
00732094322989Welch Allyn, Inc.901134ESCRIBE-BAX-CXACA2019-07-22
00732094322996Welch Allyn, Inc.901134ESCRIBE-BAX-CXAAX2019-07-22
00732094323009Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXX2019-07-22
00732094323016Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXA2019-07-22
00732094323023Welch Allyn, Inc.901134ESCRIBE-AEX-CXAXA2019-07-22
00732094323030Welch Allyn, Inc.901134ESCRIBE-AEX-CXAAA2019-07-22
00732094323047Welch Allyn, Inc.901134ESCRIBE-AAX-DXXXX2019-07-22
00732094323054Welch Allyn, Inc.901134ESCRIBE-AAX-CXXXX2019-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04650075334003aTympNEUROSOFT, OOOPTP2023-02-02
00732094185775Welch Allyn, Inc.WELCH ALLYN, INC.PTP2022-07-07
00732094185881Welch Allyn, Inc.WELCH ALLYN, INC.PTP2022-07-07
00732094185553Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-08-03
00732094185560Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-08-03
00732094185577Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-08-03
00732094185591Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-08-03
00732094185706Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-08-03
00732094185713Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-31
00732094185720Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-31
00732094185737Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-31
00732094185744Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-31
00732094185751Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-31
00732094185768Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-31
00732094185782Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185799Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185805Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185812Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185829Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185836Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185843Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185850Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185867Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094185874Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-07-28
00732094300581Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-03-19
00732094300598Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-03-19
00732094300604Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-03-19
00732094300611Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-03-19
00732094300628Welch Allyn, Inc.WELCH ALLYN, INC.PTP2020-03-19
04260223143694nanoTympPATH medical GmbHPTP2020-01-31