SafeSplint

Basic Information

• Brand Name: SafeSplint
• Primary DI: 00860011549505
• Version / Model: 16" Short Arm Splint
• Catalog Number: 600089
• Company Name: APARATA MEDICAL, LLC
• Labeler DUNS: 044706132
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-24
• Public Version: 1
• Public Version Date: 2025-10-02
• Public Version Status: New
• Public Device Record Key: 6cd7e1a3-9603-422a-bb37-48a970bada6a

Device Description

SafeSplint is an inflatable upper extremity splint for immobilizing the hand in the correct safe anatomical position while providing rigid immobilization of a hand, wrist or forearm injury or fracture. It is a disposable, single use bladder system that inflates through three inlet ports around a patient's upper extremity to immobilize and splint the hand, assembled and applied by a physician, and adjusted (pneumatically or mechanically) by the patient. Each package contains one (1) 16" inflatable short arm splint, one (1) 16" stockinette, one (1) manual inflation pump, one (1) instructions for use document, and one (1) patient card for device identification. Apply SafeSplint at the time of upper extremity injury prior to obtaining professional orthopedic attention. Comfortably inflate SafeSplint to fit to the patient hand in a safe anatomical position while rigidly immobilizing the fracture for patient comfort for up to fourteen (14) days. Product is waterproof and sweat wicking. Remove and reapply the splint by the physician when necessary, and adjust air pressure by patient for comfort. Not intended to replace any casts (plaster or fiberglass), be used as an alternative to orthopedic intervention, set (reduce) the fracture, or hold a fracture that's already been set (reduced). Disclaimer regarding irritation: Physicians should assess patients for adverse reactions on the skin where the device has contact, such as redness (erythema), swelling (edema), irritation, sensitization (delayed Type IV hypersensitivity), allergy, immune response, or other reactions. Physicians may use a generic stockinette with SafeSplint to proactively prevent potential irritation. SafeSplint is not intended to be used on broken skin and wounds should be treated/covered as per standard of care prior to putting the SafeSplint on.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	878.3900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67627	Inflatable extremity splint, single-use	A sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb following injury. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies to stabilize the limb for transport to a hospital, or applied by a professional for short-term use (e.g., 14 days); the air pressure may be adjusted by the patient for comfort. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011549505	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	16	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity