Duns Number:319414785
Device Description: Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
Catalog Number
-
Brand Name
TRACOE® twist
Version/Model Number
REF 401-06
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
K961449
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
0ed8cb20-6aa0-4784-a828-bf340d0dde28
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
October 18, 2015
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 | 88 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1963 |