FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094175608
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901079
Catalog number
25271
Device description
3.5V HAL OTOSCOPE SET SFT CS
Published
2020-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOTOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094175608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094175608007320941756087320941756080732094175608

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094055245Welch Allyn, Inc.WELCH ALLYN, INC.ERA2026-03-06
40050428029495CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
06972545090416JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
16972545090093JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
06974546524372TealmedNingbo Tealmed Emergency Products Co., Ltd.ERA2026-01-16
00850042909218ProsidioProsidio LLCERA2025-12-05
00850042909225ProsidioProsidio LLCERA2025-12-05
00850042909256ProsidioProsidio LLCERA2025-12-05
00850042909263ProsidioProsidio LLCERA2025-12-05
00850042909270ProsidioProsidio LLCERA2025-12-05
00850042909287ProsidioProsidio LLCERA2025-12-05
00850042909294ProsidioProsidio LLCERA2025-12-05
00850042909300ProsidioProsidio LLCERA2025-12-05
00850042909317ProsidioProsidio LLCERA2025-12-05
00850042909324ProsidioProsidio LLCERA2025-12-05
00850042909331ProsidioProsidio LLCERA2025-12-05
00850042909348ProsidioProsidio LLCERA2025-12-05
00850042909355ProsidioProsidio LLCERA2025-12-05
00850042909362ProsidioProsidio LLCERA2025-12-05
00850042909379ProsidioProsidio LLCERA2025-12-05
00850042909386ProsidioProsidio LLCERA2025-12-05
00850042909393ProsidioProsidio LLCERA2025-12-05
00850042909409ProsidioProsidio LLCERA2025-12-05
00850042909416ProsidioProsidio LLCERA2025-12-05
00850042909423ProsidioProsidio LLCERA2025-12-05
00850042909430ProsidioProsidio LLCERA2025-12-05
00850042909447ProsidioProsidio LLCERA2025-12-05
00850042909454ProsidioProsidio LLCERA2025-12-05
00850042909461ProsidioProsidio LLCERA2025-12-05
00850042909478ProsidioProsidio LLCERA2025-12-05