AccessGUDID - DEVICE: AincA® (B005003870)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: 00-387
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-387
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005003870
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Valve, Bag-Tail Bleed, Denison Adjustable Type, Lightweight, 3/8" Nipple, Gold Colored Aluminum

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?
37038	Ventilator converter	A device intended to be used to couple together any type of powered ventilator to any kind of breathing circuit system, making them compatible for use. By using this device it is then possible to use alternative combinations of ventilator and breathing circuit from different manufacturers. This will assist, e.g., a hospital to be flexible in the choice of breathing circuit or system and allowing for the introduction to new kinds whilst the ventilators may remain the same. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFE	VALVE, SWITCHING (PLOSS)

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
No Device Sizes

Device Record Status

Public Device Record Key: a455d933-2544-4714-a7b2-736fe23bf08d
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021