Duns Number:033809722
Device Description: A curved metal or plastic tube inserted through the mouth to facilitate airway patency for A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.
Catalog Number
11150100
Brand Name
Forsure
Version/Model Number
11150100
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
-
Product Code
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
ecb01375-af75-4bc5-bd3c-860ccaa44ca0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 13, 2018
Package DI Number
20815123012847
Quantity per Package
45
Contains DI Package
10815123012840
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 |