Duns Number:001061233
Device Description: Dale Bariatric Tracheostomy Tube Holder, 1.5" wide, fits up to 28" neck.
Catalog Number
244
Brand Name
Dale 244 Blue
Version/Model Number
244
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
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
152e8661-af14-4a17-8624-2678557302f5
Public Version Date
September 27, 2018
Public Version Number
1
DI Record Publish Date
August 27, 2018
Package DI Number
H84102442
Quantity per Package
10
Contains DI Package
H84102441
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 74 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |