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510(k) Data Aggregation
K Number
K232836Device Name
Family of DIMAR DMAX NIV masks
Manufacturer
Dimar S.p.A
Date Cleared
2024-08-14
(335 days)
Product Code
CBK, BZD
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Dimar S.p.A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation.
The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency.
For single patient use in the Hospital environment
The mask is to be used on patients who are appropriate candidates for noninvasive ventilation.
The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg
Device Description
FAMILY OF DIMAR DIMAX NIV MASKS consists of two main types of a patient interface:
- DIMAX ZERO
- DIMAX
The DIMAX ZERO MASK is a "total face" MASK that totally covers eyes, nose and mouth. The DIMAX ZERO MASK is provided for SINGLE USE.
Below a short summary of the technical features of the DIMAX ZERO MASK:
- The MASK can be connected to 2 different connectors: 1 for gas inlet and the other one for ● the exhaust gas outlet (the mask can also work with 1 connector, with the hole for the second connector - gas outlet- capped);
- The MASK is fixed to the head of the patient through a 5 fixing points headgear;
- A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
- 2 specific luer ports are available for the control of the pressure through a manometer;
- The DIMAX ZERO MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
- 22F Non-Vented connector; O
- 22F Vented connector with flop; O
- 22F Non-Vented connector with FBS port; O
- 22M-22M adapter; O
- o 22F-22F adapter;
- о 22F сар.
The DIMAX MASK is a "Total Face" MASK that totally covers eyes, nose and mouth. The DIMAX MASK is provided for SINGLE USE.
Below a short summary of the technical features of the DIMAX MASK:
- The MASK can be connected through the same connector for both gas inlet and exhaust gas ● outlet;
- The MASK is fixed to the head of the patient through a 5 fixing points headgear;
- A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
- 2 specific luer ports are available for the control of the pressure through a manometer;
- The DIMAX MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
- O 22F Non-Vented connector;
- O 22F Vented connector with flop;
- O 22F Non-Vented connector with FBS port.
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