SafeSplint 600089

GUDID 00860011549505

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.

APARATA MEDICAL, LLC

Inflatable extremity splint, single-use

• Primary Device ID: 00860011549505
• NIH Device Record Key: 6cd7e1a3-9603-422a-bb37-48a970bada6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSplint
• Version Model Number: 16" Short Arm Splint
• Catalog Number: 600089
• Company DUNS: 044706132
• Company Name: APARATA MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com
• Phone: 407-917-4731
• Email: info@aparatamedical.com

Device Dimensions

• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011549505 [Primary]

FDA Product Code

• FZF: Splint, Extremity, Inflatable, External

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-02
• Device Publish Date: 2025-09-24