AccessGUDID - DEVICE: KC 040 - 22mm ID Reusable Ventilator Tubing (M996KC0400)

GUDID

Device Identifier (DI) Information

Brand Name: KC 040 - 22mm ID Reusable Ventilator Tubing
Version or Model: KC 040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996KC0400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: KC 040, 22mm ID, 40" length - Reusable Ventilator Tubing - polyester elastomer tube with silicone rubber cuffs

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):	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?
37705	Ventilator breathing circuit, reusable	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. 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: Yes

Sterilization Method [?]
Liquid Chemical
Ethylene Oxide
Moist Heat or Steam Sterilization

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: 13a68243-3651-46b2-a0c7-57fbba6dcc13
Public Version Date: December 11, 2019
Public Version Number: 3
DI Record Publish Date: April 14, 2017