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510(k) Data Aggregation
K Number
K013200Device Name
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
Manufacturer
Date Cleared
2001-12-14
(80 days)
Product Code
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
RENNELS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Contami-Shield ™ Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. For Single Patient Use.
Device Description
The Contami-Shield Breathing Circuit Sleeve, indicated for use with mechanicallyventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. The disclosed device is an external device, not in physical contact with the patient, intended for use with ventilators, anesthesia machines, and open flow systems where the external protection of the breathing circuit is desired. The disclosed device shall be slipped over the external surface of the breathing circuit prior to use. A filter or HME filter may be changed or removed from the breathing circuit, while the Contami-Shield is present and in use, if desired.
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