FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094083798
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
24320-B
Device description
Welch Allyn SofSeal Disposable Ear Specula; Qty. 80
Published
2020-06-22
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETYTester, auditory impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094083798PackageGS16In Commercial Distribution
00732094011968PrimaryGS10
00732094218640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094083798007320940837987320940837980732094083798
00732094011968007320940119687320940119680732094011968
00732094218640007320942186407320942186400732094218640

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

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
80
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

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Primary DI, Brand, Company table
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08051597160051ResonanceM.R.S. SRLETY2025-09-01
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05060488902680Amplivox AMPLIVOX LIMITEDETY2023-12-22
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00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
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05713315009389Madsen ZodiacNatus Medical Denmark ApSETY2022-12-12
05713315009464Madsen ZodiacGn Otometrics A/SETY2022-12-05
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05713315009495Madsen ZodiacGn Otometrics A/SETY2022-12-05
05713315009563Madsen ZodiacGn Otometrics A/SETY2022-12-05
05713315009648Madsen ZodiacGn Otometrics A/SETY2022-12-05
05713315009723Madsen ZodiacGn Otometrics A/SETY2022-12-05
05713315009778Madsen ZodiacGn Otometrics A/SETY2022-12-05
05713315009846Madsen ZodiacGn Otometrics A/SETY2022-12-05
04260223143700TY-MAPATH medical GmbHETY2022-01-17
04260223143717TY-MA Set PATH medical GmbHETY2022-01-17
05713315009013MadsenGn Otometrics A/SETY2021-08-11
05711117180282InteracousticsInteracoustics A/SETY2021-06-03
00732094300642Welch Allyn, Inc.WELCH ALLYN, INC.ETY2021-05-06