AccessGUDID - DEVICE: LMA AIRWAY MANAGEMENT (05060112313455)

GUDID

Device Identifier (DI) Information

Brand Name: LMA AIRWAY MANAGEMENT
Version or Model: IPN041132
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105300-000010
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 05060112313455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: LMA Unique™ (Silicone Cuff) Size 1

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Dark cool environment avoid direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size 1

Device Record Status

Public Device Record Key: 3beb4f1c-5847-4cc4-8415-1aa00dda87e8
Public Version Date: February 22, 2021
Public Version Number: 3
DI Record Publish Date: September 15, 2018