Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094056372
• Version / Model: 901001
• Catalog Number: 293600
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-06-22
• Public Version: 4
• Public Version Date: 2022-06-24
• Public Version Status: Update
• Public Device Record Key: 068bc3db-2ab9-4ccb-9eed-805d4a4b2e9e

Device Description

Welch Allyn Earwash Tips for Ear Wash System, Qty. 25

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35348	Self-retaining ear speculum	A hand-held manual instrument which typically comprises two arms joined at a pivot point and designed for expanding or stretching the tissue around the ear orifice when inserted and opened. It has a blunt distal tip and is used for examination or surgery, typically during ear/nose/throat (ENT) intervention. It is usually made of stainless steel with a self-retaining or adjustable mechanism and is available in various sizes, shapes and contours. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00732094081572	GS1		4	In Commercial Distribution
Primary	00732094056372	GS1
Unit of Use	00732094147827	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]