Duns Number:002348191
Device Description: Connecting Tube
Catalog Number
230100-000000
Brand Name
RUSCH
Version/Model Number
IPN004567
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
K951046,K951046,K951046
Product Code
BSK
Product Code Name
Cuff, tracheal tube, inflatable
Public Device Record Key
8366ce42-f8f5-4213-9f19-94dccc8ae469
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
24026704034547
Quantity per Package
10
Contains DI Package
04026704034543
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |