Duns Number:622637098
Device Description: Adult Trach Tube Holder
Catalog Number
301-Beige
Brand Name
Trach Tie
Version/Model Number
301-Beige
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
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
d89492c7-1c4a-46d6-be6e-048a42f549ea
Public Version Date
April 27, 2020
Public Version Number
1
DI Record Publish Date
April 17, 2020
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 | 49 |