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510(k) Data Aggregation
K Number
K961832Device Name
BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
Manufacturer
Date Cleared
1996-09-06
(116 days)
Product Code
Regulation Number
868.5540Why did this record match?
Applicant Name (Manufacturer) :
BLUE RIDGE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.
Device Description
This device is a molded plastic cover for a larvngoscope blade. It is made in two models, for either the Miller #2 or the MacIntosh #3 laryngoscope blade. Also, a portion of the device covers the upper portion of the laryngoscope handle. The device functions to cover the laryngoscope blade prior to use in the mouth. The device is made of a linear low density polycthylene copolymer, approved by the FDA, 21 CFR 177,1520, and is 1 mm thick. The master file number is #11624. It is made to conform to the laryngoscope blade. The cover adheres to the laryngoscope blade by a plastic clip that is formed from the plastic matcrial that encircles the top of the laryngoscope handle. It is a single use device
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