DEVICE: LMA AIRWAY MANAGEMENT (15060112317252)

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Device Record History
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Device Identifier (DI) Information
LMA AIRWAY MANAGEMENT
IPN916589
In Commercial Distribution
145010
TELEFLEX INCORPORATED
15060112317252
GS1

1
002348191 *Terms of Use
LMA(R) Unique(TM) PreCurved Size 1
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Device Characteristics
MR Conditional
No
No
Yes
No
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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
5f57e6d7-de53-4fac-b957-5ebc622c820c
July 19, 2023
2
March 16, 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
25060112317259 10 15060112317252 In Commercial Distribution Box
35060112317256 5 25060112317259 In Commercial Distribution Carton
45060112317253 36 35060112317256 In Commercial Distribution Pallet
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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