DEVICE: LMA AIRWAY MANAGEMENT (15060112316231)

Device Identifier (DI) Information

LMA AIRWAY MANAGEMENT
IPN056590
In Commercial Distribution
ALAA020SU
TELEFLEX INCORPORATED
15060112316231
GS1

1
002348191 *Terms of Use
LMA Unique™ Size 2
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Device Characteristics

MR Safe
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?
45036 Laryngeal mask airway, single-use
A curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Dark cool environment avoid direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Size 2
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Device Record Status

3b4f2fa8-5d4f-4ed5-a26d-8dd3c54dd320
June 30, 2021
1
June 22, 2021
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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
25060112316238 10 15060112316231 In Commercial Distribution Box
45060112316232 36 35060112316235 In Commercial Distribution Pallet
35060112316235 5 25060112316238 In Commercial Distribution Carton
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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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