Duns Number:002348191
Device Description: Endotracheal Tube Holder Cushion
Catalog Number
1066
Brand Name
HUDSON RCI
Version/Model Number
IPN049310
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBH
Product Code Name
DEVICE, FIXATION, TRACHEAL TUBE
Public Device Record Key
04f1f64d-3f2e-48bf-b352-9951f4ca72ad
Public Version Date
August 19, 2020
Public Version Number
3
DI Record Publish Date
September 12, 2018
Package DI Number
34026704630104
Quantity per Package
50
Contains DI Package
14026704630100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |