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type 9291 interface respirator
S & W Medico Teknik
Summary: The Type 9291 Interface Respirator is a medical device used for respiratory support, primarily in surgical and critical care settings. It is typically used by anesthesiologists and critical care specialists.
FDA Clearance Information
Pathway
510K
Number
K896736 ↗
Decision Date
February 28, 1990
Product Code
CBK
Device Class
Class 2
Evidence
0 studies
The Type 9291 Interface Respirator was cleared through the FDA 510k pathway on February 28, 1990. Manufactured by S & W Medico Teknik, it is classified as a Class 2 device under product code CBK.
What It Is
The Type 9291 Interface Respirator is a device designed to assist or replace spontaneous breathing in patients. It interfaces with the patient's airway to deliver controlled ventilation, ensuring adequate oxygenation and carbon dioxide removal. This device is crucial in settings where patients are unable to maintain adequate ventilation on their own, such as during anesthesia or in intensive care units.
Clinical Applications
Commonly used in operating rooms and intensive care units, the Type 9291 Interface Respirator is vital for managing patients undergoing surgery or those with respiratory failure. It is used by anesthesiologists during surgical procedures to maintain ventilation and by critical care specialists in ICUs for patients with compromised respiratory function. The device is suitable for both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA indications suggest that this respirator is intended for patients who require respiratory support due to inadequate spontaneous breathing. This includes conditions like acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) exacerbations, or during general anesthesia.
Practical Considerations
The Type 9291 Interface Respirator is typically available in various sizes to accommodate different patient anatomies. It is compatible with standard ventilator systems and requires proper training for effective use. Clinicians should ensure proper fit and seal to optimize ventilation efficiency.
Frequently Asked Questions
What is the Type 9291 Interface Respirator used for?
It is used for providing respiratory support to patients who cannot breathe adequately on their own.
What specialties typically use this device?
Anesthesiologists and critical care specialists commonly use this device in surgical and intensive care settings.
What are the FDA-cleared indications?
It is indicated for patients requiring respiratory support due to inadequate spontaneous breathing, such as during surgery or in cases of respiratory failure.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.