Atos Medical

Basic Information

• Brand Name: Atos Medical
• Primary DI: 00817126020894
• Version / Model: 2010-064
• Catalog Number: 2010-064
• Company Name: ATOS MEDICAL INC.
• Labeler DUNS: 008224748
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-15
• Public Version: 4
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 00ef230b-81a5-4946-ab88-8488dcc7c9da
• Distribution End Date: 2022-03-31

Device Description

2010-064 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/55 and Provox® Adhesives

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	No	Active
35752	Tracheostomy tube neck holder, reusable	A noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.	No	Active
34883	Airway device cleaning utensil, noninvasive, reusable	A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.	No	Active
58075	In vitro ultraviolet blood irradiator	An electrically-powered device designed for the in vitro irradiation of blood and/or blood components with ultraviolet (UV) radiation, typically used in blood banks for the prevention of transfusion-associated transmission of pathogens, or in healthcare facilities for off-line photoimmunotherapy of a leukocyte-enriched blood fraction as a treatment for cutaneous T-cell lymphoma [CTCL]. It operates off-line (i.e. the blood is not returned to the patient in a closed circuit) and consists of a cabinet chamber and a source of UV light (UVA, B, or C is used according to intended use), and may also include tubes and pumps for continuous flow processing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817126020894	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Do not store in direct sunlight.
• Type: Handling Environment Temperature
• Temperature Range: 36 – 108 Degrees Fahrenheit