AccessGUDID - DEVICE: AincA® (B005LF390200)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: LF-390-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LF-390-20
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005LF390200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Mask, Laryngeal Airway, UltraFlex EX, Size 2.0 (6.4mmID), 15mmM, 40xReusable-Reinforced, Silicone

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2

Device Record Status

Public Device Record Key: 8292e42e-3558-4fff-ab4d-bfbb24ca9833
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021