FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094300598
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
93750
Device description
MT4 4 IN 1 TEST CAVITY ASSEMBLY
Published
2020-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
00732094300598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094300598007320943005987320943005980732094300598

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, automatedAn electroacoustic device designed to be used in a clinical setting to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. A computer or microprocessor in the device automatically produces tones that sweep the audiometric scale and controls tone intensity and frequency. The device also records the patient's responses and may display calculated hearing thresholds. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.

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
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05
00732094209921Welch Allyn, Inc.90105874CE-B2017-12-05

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
00732094185584Welch 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
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