AccessGUDID - DEVICE: Prevantics® Device Swab (00310819001526)

GUDID

Device Identifier (DI) Information

Brand Name: Prevantics® Device Swab
Version or Model: B19600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B19600
Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

Primary DI Number: 00310819001526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800777117 *Terms of Use

Device Description: Pre-moistened swab to disinfect needleless access sites prior to 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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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
LKB	Pad, Alcohol, Device Disinfectant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132380	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 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.034 Fluid Ounce

Device Record Status

Public Device Record Key: 50d1a2cf-7f99-4e0f-beac-beb21966d74f
Public Version Date: August 11, 2020
Public Version Number: 1
DI Record Publish Date: August 03, 2020