Duns Number:002348191
Device Description: TFX ISIS HVT WITH STYLET 8.5
Catalog Number
5-14017
Brand Name
TELEFLEX
Version/Model Number
IPN044830
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
K091761,K091761,K091761
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
5849100b-1383-432e-95a0-8063c8f31aaa
Public Version Date
October 04, 2019
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
44026704588440
Quantity per Package
10
Contains DI Package
24026704588446
Package Discontinue Date
September 30, 2019
Package Status
Not 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 | 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 |