FDA.reportPublic FDA data

OralKleen

Primary DI
00850030081056
Brand
OralKleen
Company
Oralkleen, LLC
Model
V1.1
Catalog number
615-0110
Device description
Oral Hygiene Kit
Published
2024-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSBPatient Personal Hygiene Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030081056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030081056008500300810568500300810560850030081056

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
602-767-2422contact@oralkleen.com

Regulatory Flags#

DUNS number
122347960
Device count
1
Premarket exempt
true
Kit
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030081124OralKleen™V1.2715-00802025-10-22
00850030081063OralKleen™V1.1715-00762024-09-12
00850030081018OralKleenV1615-01002022-11-15
00850030081001OralKleenV1715-00202022-11-15
10850030081015OralKleenV1615-01002022-11-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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