Duns Number:033809722
Device Description: A sterile hollow cylinder designed to be inserted into an artificial opening made in the t A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.
Catalog Number
11110080
Brand Name
Forsure
Version/Model Number
11110080
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042684,K042684,K042684
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
8032829e-044b-4a53-9378-55584e83df5d
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
December 14, 2017
Package DI Number
20815123011475
Quantity per Package
100
Contains DI Package
10815123011478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |