FDA.report

LMA AIRWAY MANAGEMENT

Primary DI
45060112314733
Brand
LMA AIRWAY MANAGEMENT
Company
TELEFLEX INCORPORATED
Model
IPN915395
Catalog number
130099
Device description
LMA Fastrach™ Stabiliser Rod
Published
2021-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15060112314732Direct MarkingGS10
35060112314736PackageGS110In Commercial Distribution
45060112314733PackageGS110In Commercial Distribution
25060112314739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1506011231473215060112314732
3506011231473635060112314736
4506011231473345060112314733
2506011231473925060112314739

GMDN Terms

TermDefinition
Endotracheal tube stabilization rodA non-sterile device intended to be used to facilitate exchange of an in situ laryngeal airway for an endotracheal tube (ETT) by stabilizing the position of the inserted ETT as the laryngeal airway is withdrawn. It typically consists of a semi-flexible rod which functions as an extension of the ETT during the exchange. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Dark cool environment avoid direct sunlight

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16946430425208CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425215CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425222CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425239CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425246CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425253CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425260CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425277CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425284CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425291CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425307CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425314CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425321CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425338CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425345CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425352CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425369CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425376CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425383CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425390CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425406CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425413CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425420CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425437CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425444CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
45060112316102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-12-10
35060112316112LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-11-17
00840117340428Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender Dynarex CorporationCAE2025-09-29
25060112310618LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
15060112311038LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11