AccessGUDID - DEVICE: KC 211-D 60 degree Angle Wye Connector (M996KC211D0)

GUDID

Device Identifier (DI) Information

Brand Name: KC 211-D 60 degree Angle Wye Connector
Version or Model: KC 211-D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KC 211-D
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996KC211D0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: KC 211-D Wye connector with one - 18mm ID/22mm OD nebulizer port x (3) 22mm OD ports. Fits components of adult ventilator circuits. Single Patient Use.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
43435	Y-piece breathing circuit connector, single-use	A connecting device shaped in the form of a "Y" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is typically made of light plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

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 [?]
Hydrogen Peroxide
High-level Disinfectant

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: df2ba2ac-2a02-41fd-b0e9-28ea57fc6707
Public Version Date: May 20, 2019
Public Version Number: 1
DI Record Publish Date: May 11, 2019