Duns Number:002348191
Device Description: CARLENS BRONCHIAL DOUBLE LUMEN TUBE SET (LEFT), STERILE
Catalog Number
116101410
Brand Name
RUSCH
Version/Model Number
IPN041707
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"
Yes
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
K141888,K141888,K141888
Product Code
CBI
Product Code Name
TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Public Device Record Key
b3698532-8963-43a9-91e9-945a3ab2f8a9
Public Version Date
October 28, 2020
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
44026704344299
Quantity per Package
24
Contains DI Package
24026704344295
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |