Duns Number:033809722
Device Description: A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed a A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.
Catalog Number
11250075
Brand Name
Forsure
Version/Model Number
11250075
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
K042683,K042683,K042683
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
84b55593-51f8-470d-89bf-88291648188f
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 23, 2018
Package DI Number
20815123012199
Quantity per Package
100
Contains DI Package
10815123012192
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CASE
| 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 |