FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NSBPatient Personal Hygiene Kit

Product Code Classifications

CodeDeviceSpecialtyClass
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850030081056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030081056008500300810568500300810560850030081056

GMDN Terms

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

Contacts

PhoneEmail
602-767-2422contact@oralkleen.com

Regulatory Flags

DUNS number
122347960
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850030081063OralKleen™V1.1715-00762024-09-12
00850030081001OralKleenV1715-00202022-11-15
10850030081015OralKleenV1615-01002022-11-15

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