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APARATA MEDICAL

Matched from indexed company URL: APARATA MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30309793783030979378APARATA MEDICAL1N2026-01-011126 S Division Ave Orlando FL US 32805

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860011549505SafeSplint - "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. "407-917-4731info@aparatamedical.com
G8057116571Bleed ID - "The Bleed ID Suction Pad is a 32""x32"" collection device intended for use in obstetrics and gynecological procedures to aid the clinician in the detection of blood loss. The Bleed ID Suction Pad is intended to be powered by a single-source vacuum and used with collection canisters."4079174731info@aparatamedical.com

Registered Device Listings#

Registration key, Listing key table
Registration keyListing key
3276811176597117
3276811622561358

GUDID#

SafeSplint - "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

2025-09-24