DEVICE: TELEFLEX (04026704588411)
Device Identifier (DI) Information
TELEFLEX
IPN044827
In Commercial Distribution
5-14014
TELEFLEX INCORPORATED
IPN044827
In Commercial Distribution
5-14014
TELEFLEX INCORPORATED
TFX ISIS HVT WITH STYLET 7.0
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47691 | Cuff-suction endotracheal tube |
A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTR | Tube, tracheal (w/wo connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091761 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 15 Millimeter |
Device Size Text, specify: Tracheal Tube, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet |
Device Record Status
922101ea-69f9-4223-a771-95c7b61e3930
October 04, 2019
4
October 16, 2015
October 04, 2019
4
October 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
44026704588419 | 10 | 24026704588415 | 2019-09-30 | Not in Commercial Distribution | Case |
24026704588415 | 10 | 04026704588411 | 2019-09-30 | Not in Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(919)544-8000
CS@TELEFLEX.COM
CS@TELEFLEX.COM