Duns Number:106712748
Catalog Number
-
Brand Name
Portex
Version/Model Number
101/506/035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K170720,K170720,K170720
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
3cd3925e-c8d8-4c61-9bf6-dd366c002695
Public Version Date
June 05, 2020
Public Version Number
5
DI Record Publish Date
March 29, 2018
Package DI Number
35019517046193
Quantity per Package
10
Contains DI Package
15019517046199
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |