Duns Number:053146767
Device Description: The BE114-5TB Flexible Support Arm Single Tubing Clamp holds a ventilator tube in place wh The BE114-5TB Flexible Support Arm Single Tubing Clamp holds a ventilator tube in place when attached to an III "Flexible Support Arm". Made of polypropylene with phenolic ball knob mount. Made in the USA.
Catalog Number
BE 114-5TB
Brand Name
BE114-5TB Flexible Support Arm Single Tubing Clamp
Version/Model Number
BE 114-5TB
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
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
6c6bc80d-8b26-4533-a44c-219e527e9dc8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |