Duns Number:002348191
Device Description: Standard connector 15 mm
Catalog Number
501063-000105
Brand Name
RUSCH
Version/Model Number
IPN044623
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
-
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
K931166,K931166,K931166,K931166
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
60b56e30-45ab-4504-9d68-2f792d6b0f96
Public Version Date
October 21, 2020
Public Version Number
6
DI Record Publish Date
September 20, 2016
Package DI Number
44026704063398
Quantity per Package
344
Contains DI Package
24026704063394
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |