AccessGUDID - DEVICE: AincA® (B00500309065009)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: 00-309-06-500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-309-06-500
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B00500309065009
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Connector, ET Tube, Straight, 15mmM x 6mm ID Nipple, Disposable PP Plastic. Package of 500.

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:	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?
42988	Low-pressure tubing connector, reusable	A device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	CONNECTOR, AIRWAY (EXTENSION)

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
Lumen/Inner Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: 1dab29f7-63f3-47a2-b70a-2bac7261cfa4
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021