mBrace 4285 Wrist Support with Hook

Basic Information

• Brand Name: mBrace 4285 Wrist Support with Hook
• Primary DI: 10815614021092
• Version / Model: 4285
• Catalog Number: 140-0285-00
• Company Name: Semler Technologies, Inc.
• Labeler DUNS: 042075700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-27
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: b07e11db-5f6c-4e80-b24f-3aa11cc18a4d

Device Description

The mBrace Model 4285 is a wrist support device that extends the patient's wrist at a consistent 30°angle with a syringe clip to attach a syringe and with a hook to integrate with an ArmBoard. The mBrace Model 4285 has a valley in the area below the wrist to allow a hemostasis device strap to be easily applied.

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: Yes
• 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
FMQ	Restraint, Protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45128	Wrist splint, single-use	A rigid external support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815614021092	GS1
Package	20815614021099	GS1	Case	30	In Commercial Distribution