Duns Number:215591523
Catalog Number
-
Brand Name
Portex
Version/Model Number
6956
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
BTO
Product Code Name
Tube, tracheostomy (w/wo connector)
Public Device Record Key
2ceb5c95-1712-43b8-853a-38e1beb1d0a7
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
September 01, 2015
Package DI Number
30351688006442
Quantity per Package
20
Contains DI Package
20351688006445
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 | 332 |
2 | A medical device with a moderate to high risk that requires special controls. | 431 |