Tyke

Basic Information

• Brand Name: Tyke
• Primary DI: 00850013379231
• Version / Model: Size 1
• Company Name: KI MOBILITY, LLC
• Labeler DUNS: 609305656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 4
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: de39282e-fcdd-4052-859a-6911c7041045

Device Description

Tyke Size 1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
INM	Chair, With Casters	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31162	Assistive pushchair	A wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013379231	GS1

Customer Contacts

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