FDA.report

LMA

Primary DI
25060112318751
Brand
LMA
Company
TELEFLEX INCORPORATED
Model
IPN922869
Catalog number
131060
Device description
LMA Fastrach™ ETT 6.0mm
Published
2022-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications

CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
45060112318755Direct MarkingGS10
25060112318751PackageGS110In Commercial Distribution
35060112318758PackageGS110In Commercial Distribution
15060112318754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4506011231875545060112318755
2506011231875125060112318751
3506011231875835060112318758
1506011231875415060112318754

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter6Millimeter

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
true

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