FDA.reportPublic FDA data

Toothette Oral Care

Primary DI
00618029821348
Brand
Toothette Oral Care
Company
SAGE PRODUCTS, LLC
Model
6594
Catalog number
6594
Device description
Q4 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029821343PackageGS120Not in Commercial Distribution
00618029821348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802982134350618029821343
00618029821348006180298213486180298213480618029821348

GMDN Terms#

Term, Definition table
TermDefinition
Oral care swabA device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-2220customer-service-spcl@sageproducts.com

Regulatory Flags#

DUNS number
054326178
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618029831118Q-Care906290622018-08-10
00618029980274Stryker Fecal Management System700-128700-1282023-03-07
00618029720801Sage Air Tap LC728772872019-10-01
07613327680720Q-Care682268222025-12-03
07613327680737Q-Care694269422025-12-03
07613327680744Q-Care698469842025-12-03
07613327680751Q-Care682468242025-12-03
57613327680725Q-Care682268222025-12-03
57613327680732Q-Care694269422025-12-03
57613327680749Q-Care698469842025-12-03
57613327680756Q-Care682468242025-12-03
07613327632842Sage Multi-Position MATS 2.0323432342025-11-19
07613327632859Sage325032502025-11-19
07613327632866Sage325132512025-11-19
07613327672718Sage Multi-Position MATS 2.0323132312025-11-19
00618029720856Sage AirTAP LC728972892020-04-20
00618029760869Sage Multi-Position MATS323232322021-10-15
07613327632835Sage Multi-Position MATS323332332024-08-12
07613327632873Sage TAP LC728172812024-03-26
07613327632880Sage TAP LC728272822024-03-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680720Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
10889483565339BALLARD™SUNMED, LLCNSB2025-12-01
10889483565346BALLARD™SUNMED, LLCNSB2025-12-01
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M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
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10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
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10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28