Maclaren

Basic Information

• Brand Name: Maclaren
• Primary DI: 00860014637827
• Version / Model: CM1001RD
• Catalog Number: CM1001RD
• Company Name: COCHE MOBILITY SOLUTIONS INC.
• Labeler DUNS: 004792567
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-08
• Public Version: 1
• Public Version Date: 2026-01-16
• Public Version Status: New
• Public Device Record Key: cba4c3b5-eb97-4e26-8696-8e254cd60c6c

Device Description

Adaptive Stroller, Juvenile Push Chair for children 3-10 years old requiring a mobility device. Maclaren Major Elite brand and model. Color Red

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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	00860014637827	GS1

Customer Contacts

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