Duns Number:053146767
Device Description: BE 105-8 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x15mm OD (equipment port). R BE 105-8 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x15mm OD (equipment port). Reusable. Fits components of adult ventilator circuits. Molded of polyetherimide. Includes two silicone rubber caps; one cap allows for the use of a suctioning catheter while the other cap allows for the use of a fiber-optic bronchoscope without significant loss of PEEP.
Catalog Number
BE 105-8
Brand Name
BE 105-8 Bronchoscope Swivel
Version/Model Number
BE 105-8
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
27b41106-5837-4879-9062-7f5dc803910d
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
December 08, 2017
Package DI Number
M996BE10582
Quantity per Package
10
Contains DI Package
M996BE10580
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |