AccessGUDID - DEVICE: CaviWipes1 XL (00615375004999)

GUDID

Device Identifier (DI) Information

Brand Name: CaviWipes1 XL
Version or Model: 13-5150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: METREX RESEARCH, LLC

Primary DI Number: 00615375004999
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 65
Labeler D-U-N-S® Number*: 145963778 *Terms of Use

Device Description: 1 Minute 1 Step Germicidal Wipes Fragrance Free Extra Large Canister of PreSaturated Towelettes

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:	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?
58077	Medical device cleaning/disinfection wipe	A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, medical devices

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
Special Storage Condition, Specify: Store in a cool place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Net Contents 1 lb. 15 oz. 891g Towelette Dimension 9 x 12

Device Record Status

Public Device Record Key: 8f4b8943-b69d-4ed8-beab-fd4fc04528a9
Public Version Date: May 23, 2019
Public Version Number: 3
DI Record Publish Date: August 31, 2016