DEVICE: LMA (05060112311895)

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Device Identifier (DI) Information

LMA
IPN042411
135240
TELEFLEX INCORPORATED
05060112311895
GS1
1
LMA Fastrach Combo-Kit, SU, Size 4
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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. 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 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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FDA Product Code

[?]
Product Code Product Code Name
BTR Tube, tracheal (w/wo connector)
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 37 and 39 Degrees Celsius
Handling Environment Humidity: between 80 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 25 Degrees Celsius
Special Storage Condition, Specify: Cool dark environment, avoid direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: LMA Fastrach® Combo Pack Single-Use Airway
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Device Status

In Commercial Distribution
October 23, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15060112311892 5 05060112311895 In Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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