Duns Number:001061233
Device Description: Dale PediPrints Tracheostomy Tube Holder, 1" wide, fits up to 18" neck
Catalog Number
241
Brand Name
Dale PediPrints
Version/Model Number
241
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)
-
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
49e1b74f-c6e4-4768-8483-f77e0b1026ba
Public Version Date
May 15, 2019
Public Version Number
2
DI Record Publish Date
February 19, 2019
Package DI Number
00817612020711
Quantity per Package
10
Contains DI Package
00817612020704
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 |