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510(k) Data Aggregation
K Number
K112271Device Name
3B WILLOW
Manufacturer
3B PRODUCTS, LLC
Date Cleared
2012-02-16
(192 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
3B PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Willow™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow ™ is:
(1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
(2) to be used for single-patient reuse in the home environment.
Device Description
The 3B Willow™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The 3B WillowTM is a prescription device supplied non-sterile.
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K Number
K103434Device Name
3B FLEX-LITE
Manufacturer
3B PRODUCTS, LLC
Date Cleared
2011-10-13
(324 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
3B PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3B Flex-Lite™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or a bilevel system. The 3B Flex-Lite™ is:
- to be used by adult patients (>66lb / 30 kg); (1)
- to be used for single-patient reuse in the home environment and multipatient (2) reuse in the hospital/institutional environment.
- (3) to be used in the following environments: home, hospital, and sub-acute institutions.
- intended for prescription use. (4)
Device Description
The 3B Flex-Lite™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The 3B Flex-Lite™ is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
The 3B Flex-Lite™ is a prescription device supplied non-sterile.
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