LMA

Basic Information

• Brand Name: LMA
• Primary DI: 05060112310461
• Version / Model: IPN042399
• Catalog Number: 131070
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 6
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: d896c2d3-06fa-49f7-bf20-5ad270d512d0

Device Description

LMA Fastrach™ ETT 7.0mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	35060112310462	GS1
Package	15060112310468	GS1	Box	10	In Commercial Distribution
Primary	05060112310461	GS1
Package	25060112310465	GS1	Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K991580	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	7	Millimeter
Device Size Text, specify			7.0mm ID

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dark cool environment avoid direct sunlight