Duns Number:053146767
Device Description: BE 122-24 Flexible Support Arm - 24" - (With extension, reaches 38" total length) - Use to BE 122-24 Flexible Support Arm - 24" - (With extension, reaches 38" total length) - Use to support ventilator tubing; Rotates up to 360° and can be locked in place. Adapts to most ventilators by using Flexible Support Arm Brackets. Ventilator tubing is held in place with Flexible Support Arm Tubing Clamps mounted to the Flexible Support Arm. All are manufactured in the USA by Instrumentation Industries, Inc.
Catalog Number
BE 122-24
Brand Name
BE 122-24 Flexible Support Arm
Version/Model Number
BE 122-24
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
a24f26e6-1e08-47a2-8cad-38b31cb621a5
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 |