AccessGUDID - DEVICE: KC 10 Tubing Separator (M996KC100)

GUDID

Device Identifier (DI) Information

Brand Name: KC 10 Tubing Separator
Version or Model: KC 10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KC 10
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996KC100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: KC 10 Tubing Separator separates large bore tubing from small bore tubing. Made of silicone rubber. Reusable. Made in the USA.

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?
37041	Breathing circuit tube holder	A device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)

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: 1d4b435f-6bfe-401b-bbe5-03051341d80f
Public Version Date: June 10, 2019
Public Version Number: 1
DI Record Publish Date: May 31, 2019