Duns Number:002348191
Device Description: ET TUBE, PREFORMED CUFFED ORAL, 8.0
Catalog Number
5-22216
Brand Name
HUDSON RCI
Version/Model Number
IPN048938
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
K822082,K822082,K822082,K822082
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
3081fe01-9a82-4a39-a094-9c18ddbe0f5c
Public Version Date
January 20, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2018
Package DI Number
44026704617744
Quantity per Package
10
Contains DI Package
34026704617747
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 |