DEVICE: RUSCH (04026704005512)
Device Identifier (DI) Information
RUSCH
IPN040991
In Commercial Distribution
104004-000050
TELEFLEX INCORPORATED
IPN040991
In Commercial Distribution
104004-000050
TELEFLEX INCORPORATED
Armoured tracheal tube, cuffed
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
46569 | Reinforced endotracheal tube, single-use |
An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.
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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 [?] |
---|---|
K955495 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight; Keep dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 5 Millimeter |
Device Size Text, specify: 5.0 |
Outer Diameter: 7.8 Millimeter |
Device Record Status
9832fd54-2a9c-45b8-8999-fe2e9c7083a6
June 03, 2019
3
October 16, 2015
June 03, 2019
3
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 |
---|---|---|---|---|---|
24026704005516 | 2 | 04026704005512 | 2018-03-21 | Not in Commercial Distribution | Box |
44026704005510 | 98 | 24026704005516 | 2018-03-21 | Not in Commercial Distribution | Carton |
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