FDA.reportPublic FDA data

OralKleen

Primary DI
10850030081015
Brand
OralKleen
Company
Oralkleen, LLC
Model
V1
Catalog number
615-0100
Device description
Oral Hygiene Kit
Published
2022-11-15
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

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
10850030081015PackageGS120In Commercial Distribution
00850030081018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003008101510850030081015
00850030081018008500300810188500300810180850030081018

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030081124OralKleen™V1.2715-00802025-10-22
00850030081056OralKleenV1.1615-01102024-09-12
00850030081063OralKleen™V1.1715-00762024-09-12
00850030081018OralKleenV1615-01002022-11-15
00850030081001OralKleenV1715-00202022-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160516577Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
20809160516574Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
10809160513859Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
20809160513856Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
10809160513330MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
20809160513337MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
07613327680720Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680732Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680749Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
10889483565315BALLARD™SUNMED, LLCNSB2025-12-01
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10889483565360BALLARD™SUNMED, LLCNSB2025-12-01
10889483565384BALLARD™SUNMED, LLCNSB2025-12-01
30889483565319BALLARD™SUNMED, LLCNSB2025-12-01
30889483565333BALLARD™SUNMED, LLCNSB2025-12-01
30889483565340BALLARD™SUNMED, LLCNSB2025-12-01
30889483565357BALLARD™SUNMED, LLCNSB2025-12-01
30889483565364BALLARD™SUNMED, LLCNSB2025-12-01
10889483565377BALLARD™SUNMED, LLCNSB2025-12-01
30889483565388BALLARD™SUNMED, LLCNSB2025-12-01
00661392004580LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392004733LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012059LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012066LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012097LSL HEALTHCARELSL Industries, LLCNSB2025-10-30