Duns Number:001061233
Device Description: Dale One Piece tracheostomy tube holder, 1" wide neckband, fits 9.5" to 18" neck.
Catalog Number
200
Brand Name
Dale 200 One Piece Holder
Version/Model Number
200
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
e9255e5b-2591-46f9-a8ab-3e5e35786ce8
Public Version Date
September 27, 2018
Public Version Number
1
DI Record Publish Date
August 27, 2018
Package DI Number
H84102002
Quantity per Package
30
Contains DI Package
H84102001
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 |