AccessGUDID - DEVICE: LMA AIRWAY MANAGEMENT (05060112310126)

GUDID

Device Identifier (DI) Information

Brand Name: LMA AIRWAY MANAGEMENT
Version or Model: IPN901662
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101020
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 05060112310126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: LMA™ Cuff Deflator Size 2 - 2½

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	No
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?
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.	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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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 2 - 2½

Device Record Status

Public Device Record Key: 01ce9e34-08a5-4645-a7cd-fce2f539ff11
Public Version Date: October 16, 2018
Public Version Number: 1
DI Record Publish Date: September 15, 2018