FDA.reportPublic FDA data

LMA AIRWAY MANAGEMENT

Primary DI
05060112313851
Brand
LMA AIRWAY MANAGEMENT
Company
TELEFLEX INCORPORATED
Model
IPN047897
Catalog number
192030
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060112313858PackageGS110In Commercial Distribution
25060112313855PackageGS15In Commercial Distribution
55060112313856PackageGS132In Commercial Distribution
05060112313851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506011231385815060112313858
2506011231385525060112313855
5506011231385655060112313856
05060112313851050601123138515060112313851

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dark cool environment avoid direct sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25
14026704928702WECKIPN930282544965T2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920687314020INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314037INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314044INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314051INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314068INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314075INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314082INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314099INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314105INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314112INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314129INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314136INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314143INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314150INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314167INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314174INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314181INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314198INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314204INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314211INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314228INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314235INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314242INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314259INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314303INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314310INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314327INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314334INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03