Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094249125
• Version / Model: 901122
• Catalog Number: 106656
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-19
• Public Version: 1
• Public Version Date: 2020-03-27
• Public Version Status: New
• Public Device Record Key: d178fc5f-ef46-4ac8-8b12-b0e9e4b33920

Device Description

3Ah LITHIUM BATTERY KIT SPOT

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKO	Refractometer, ophthalmic	Ophthalmic	886.1760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46390	Vision/eye movement analysis system	An electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094249125	GS1

Customer Contacts

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