Duns Number:791765001
Device Description: Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a 1 inch nec Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a 1 inch neck flange
Catalog Number
ADD
Brand Name
Stronghold
Version/Model Number
ADD
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"
-
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
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
49f6019d-e357-4d40-9ea6-611f62e453e4
Public Version Date
October 04, 2019
Public Version Number
1
DI Record Publish Date
September 26, 2019
Package DI Number
00860002529042
Quantity per Package
20
Contains DI Package
00860002529011
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 | 2 |