AccessGUDID - DEVICE: Wavicide MEC Indicator (M44503060)

GUDID

Device Identifier (DI) Information

Brand Name: Wavicide MEC Indicator
Version or Model: 0306-Strips
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0306-Strips
Company Name: MEDICAL CHEMICAL CORPORATION

Primary DI Number: M44503060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008496861 *Terms of Use

Device Description: The Wavicide MEC Indicator is a semi-quantitative indicator designed to monitor the glutaraldehyde concentration of Wavicide-01.

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":	No
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?
47056	Glutaraldehyde device disinfectant/sterilant test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of glutaraldehyde in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, Physical/Chemical Sterilization Process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924681	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 242a01d5-8d06-41aa-8200-7e6378069202
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016