Buddy Button - Yellow

Basic Information

• Brand Name: Buddy Button - Yellow
• Primary DI: 00186648000685
• Version / Model: 57500
• Catalog Number: 57500
• Company Name: Ablenet, Inc.
• Labeler DUNS: 791664543
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-22
• Public Version: 1
• Public Version Date: 2023-06-30
• Public Version Status: New
• Public Device Record Key: a3123b71-9e3d-48e7-87f5-7ea62f0eadab

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
KNO	Accessories, Wheelchair	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65857	Assistive electronic switch	An electronic device with a single operative feature designed to be used by a patient with a disability to activate or deactivate another device/product (e.g., toy, assistive speech generator). It is designed for use in the home and includes characteristics (size, conspicuousness, feel) to allow ease of use for a person with poor vision or other physical disability.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00186648000685	GS1