Duns Number:319414785
Device Description: comfort variant, spare inner tube with speaking valve type B, hook top
Catalog Number
n.a.
Brand Name
TRACOE® comfort
Version/Model Number
REF 888-104-07-IK1
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
K781729
Product Code
BTO
Product Code Name
Tube, tracheostomy (w/wo connector)
Public Device Record Key
361b643b-da4c-4728-a2ba-5dd5532f0bf0
Public Version Date
July 15, 2021
Public Version Number
1
DI Record Publish Date
July 07, 2021
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 |