FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094300604
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
93740
Device description
MT4 PROBE TIP AND GASKET KIT
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
00732094300604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094300604007320943006047320943006040732094300604

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
00817655023106Welch Allyn, Inc.9011454197342019-10-23
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17

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
00732094300598Welch 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