DEVICE: Provox Life LP Kit 16 - LT 10/55-2HSTP (07331791016141)
Device Identifier (DI) Information
Provox Life LP Kit 16 - LT 10/55-2HSTP
6145
In Commercial Distribution
6145
Atos Medical AB
6145
In Commercial Distribution
6145
Atos Medical AB
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use.
These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent):
Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58705 | Tracheostoma protective filter |
A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.
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Active | false |
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.
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Active | false |
63438 | Tracheostomy tube neck holder, single-use |
A non-sterile, 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 single-use device.
|
Active | false |
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.
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Active | false |
62047 | Tracheostoma shower shield |
A non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. It is typically in the form of a waterproof bib worn around the patient’s neck. This is a reusable device intended for single-patient use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OGW | Tracheostomy Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight. |
Storage Environment Temperature: between 2 and 42 Degrees Celsius |
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ecddf8bc-4bd2-42b2-b4aa-e25ef110661e
November 25, 2024
5
January 14, 2022
November 25, 2024
5
January 14, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4641519800
info@atosmedical.com
info@atosmedical.com