LMA AIRWAY MANAGEMENT

Basic Information

• Brand Name: LMA AIRWAY MANAGEMENT
• Primary DI: 05060112310133
• Version / Model: IPN901664
• Catalog Number: 101030
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-15
• Public Version: 1
• Public Version Date: 2018-10-16
• Public Version Status: New
• Public Device Record Key: d7ae534f-75fb-43d5-8a6b-8e71e5faaa66

Device Description

LMA™ Cuff Deflator Size 3 - 4

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY	Anesthesiology	868.5110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60375	Laryngeal airway cuff deflator	A non-sterile device intended to aid full deflation of a reusable laryngeal airway cuff in order to allow successful insertion, and efficacious cleaning/sterilization of the laryngeal airway. It may consist of a synthetic mould (e.g., silicone) to which the laryngeal airway cuff compresses and is manually deflated. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060112310130	GS1	Bag	10	Not in Commercial Distribution	2018-01-01
Primary	05060112310133	GS1
Package	25060112310137	GS1	Carton	5	Not in Commercial Distribution	2018-01-01

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 3 - 4

Storage Conditions

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