Duns Number:392994778
Device Description: Plain endotracheal tube (soft green tube)
Catalog Number
520.45
Brand Name
VYGON
Version/Model Number
520.45
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"
-
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
K813373,K813373,K813373
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
7766371d-2118-4d96-be65-ee76f0233e18
Public Version Date
November 23, 2020
Public Version Number
6
DI Record Publish Date
September 13, 2016
Package DI Number
53660812005819
Quantity per Package
8
Contains DI Package
33660812005815
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |