Duns Number:215591523
Catalog Number
-
Brand Name
Portex
Version/Model Number
101/541/090
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
K173912,K173912,K173912
Product Code
BTO
Product Code Name
Tube, tracheostomy (w/wo connector)
Public Device Record Key
b2f98bee-9f63-449e-bbd1-3555bd2cb7b8
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
35019517103322
Quantity per Package
1
Contains DI Package
15019517103328
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 | 332 |
2 | A medical device with a moderate to high risk that requires special controls. | 431 |