Duns Number:033809722
Device Description: A hollow cylinder that is designed for oral insertion via the trachea and into a lung to m A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.
Catalog Number
11230035
Brand Name
Forsure
Version/Model Number
11230035
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
K092886,K092886,K092886
Product Code
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
ec11b1f3-55fe-4114-a046-4f8092b2fe81
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 30, 2017
Package DI Number
20815123012106
Quantity per Package
20
Contains DI Package
10815123012109
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 |