AccessGUDID - DEVICE: OralKleen (00850030081018)

GUDID

Device Identifier (DI) Information

Brand Name: OralKleen
Version or Model: V1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 615-0100
Company Name: Oralkleen, LLC

Primary DI Number: 00850030081018
Issuing Agency: GS1
Commercial Distribution End Date: September 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 122347960 *Terms of Use

Device Description: Oral Hygiene Kit

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):	No
Kit:	Yes
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?
45174	Oral care kit, reusable	A collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. It's use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSB	Patient Personal Hygiene Kit

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: 12db9732-e828-424a-bf1b-5a20bbf8040f
Public Version Date: September 13, 2024
Public Version Number: 2
DI Record Publish Date: November 15, 2022