DEVICE: LMA (05060112311888)
Device Identifier (DI) Information
LMA
IPN042410
In Commercial Distribution
135230
TELEFLEX INCORPORATED
IPN042410
In Commercial Distribution
135230
TELEFLEX INCORPORATED
LMA Fastrach Combo-Kit, SU, Size 3
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
46967 | Basic endotracheal tube, single-use |
A 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 does not include an antimicrobial agent(s). The device 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) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and 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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Cool dark environment, avoid direct sunlight |
Handling Environment Temperature: between 37 and 39 Degrees Celsius |
Storage Environment Temperature: exactly 25 Degrees Celsius |
Handling Environment Humidity: between 80 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: LMA Fastrach® Combo Pack Single-Use Airway |
Device Record Status
33e31b83-06a5-4f0f-bfc4-afe1c85b3754
January 31, 2024
7
October 23, 2015
January 31, 2024
7
October 23, 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 |
---|---|---|---|---|---|
15060112311885 | 5 | 05060112311888 | 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
[?]
No Customer Contact currently defined