Duns Number:053146767
Device Description: Ventilator Tubing Accessory - Swivel Tubing Clamp. Swivels 360 degrees; fits tubing and r Ventilator Tubing Accessory - Swivel Tubing Clamp. Swivels 360 degrees; fits tubing and rails 1/2" to 1" inch diameter.
Catalog Number
BE 102
Brand Name
BE 102 Swivel Tubing Clamp
Version/Model Number
BE 102
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
0004a0f0-043d-4eff-8a87-aacf1d19e63b
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
April 26, 2019
Package DI Number
M996BE1026
Quantity per Package
100
Contains DI Package
M996BE1020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Polybag
| 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 |