FDA.report

Welch Allyn, Inc.

Primary DI
00732094185751
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
39422-13-100
Device description
Single Use Ear Tips for OAE Hearing Screener and MicroTymp 4 Portable Tympanometer; 13 mm; Qty. 100
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PTPTympanometer, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PTPTympanometer, ExemptEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094185751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094185751007320941857517320941857510732094185751

GMDN Terms

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

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
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00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
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00732094309225Welch Allyn, Inc.90105744XT2021-04-26
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Other Devices Sharing Product Codes

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
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