FDA.reportPublic FDA data

Non-sterile Oral Care Suction Toothbrush

Primary DI
06971092638157
Brand
Non-sterile Oral Care Suction Toothbrush
Company
Shijiazhuang Yuanding Medical Device Co., LTD
Model
Suction type
Catalog number
YDAK
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971092638154PackageGS130In Commercial Distribution
06971092638157PrimaryGS10
86971092638153Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697109263815416971092638154
06971092638157069710926381576971092638157
8697109263815386971092638153

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated manual toothbrushA non-powered instrument designed to be used by a healthcare provider/caregiver to manually brush clean the teeth and gums of a disabled/geriatric patient while simultaneously removing excess oral fluid (saliva, toothpaste). It consists of a proximal handle with a distal bristle head and an integrated suction cannula. It is intended to be used in conjunction with a suction pump (not included). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store it in a ventilated and dry room without corrosion gas, away from sources of ignition.

Regulatory Flags#

DUNS number
560446074
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971092638096Sterile Oral Care Suction ToothbrushType AYDSAK2025-02-11
06971092638102Sterile Oral Care Suction ToothbrushType AYDSAP2025-02-11
06971092638119Sterile Oral Care Suction ToothbrushType BYDSBK2025-02-11
06971092638126Sterile Oral Care Suction ToothbrushType BYDSBP2025-02-11
16971092638093Sterile Oral Care Suction ToothbrushType AYDSAK2025-02-11
16971092638109Sterile Oral Care Suction ToothbrushType AYDSAP2025-02-11
16971092638116Sterile Oral Care Suction ToothbrushType BYDSBK2025-02-11
16971092638123Sterile Oral Care Suction ToothbrushType BYDSBP2025-02-11
06971092637976Yankauer HandleCrown top with holeYDSCH2025-02-10
06971092637983Yankauer HandleCrown top without holeYDSCW2025-02-10
06971092637990Yankauer HandleFlat top with holeYDSPH2025-02-10
06971092638003Yankauer HandleFlat top without holeYDSPW2025-02-10
86971092637972Yankauer HandleCrown top with holeYDSCH2025-02-10
86971092637989Yankauer HandleCrown top without holeYDSCW2025-02-10
86971092637996Yankauer HandleFlat top with holeYDSPH2025-02-10
86971092638009Yankauer HandleFlat top without holeYDSPW2025-02-10
86971092638153Non-sterile Oral Care Suction ToothbrushSuction typeYDAK2025-02-10
06971092636702Suction Connection Tube with HandleCrown top with hole 1500mmYDSCH15002024-11-13
06971092636719Suction Connection Tube with HandleCrown top with hole 1700mmYDSCH17002024-11-13
06971092636726Suction Connection Tube with HandleCrown top with hole 1800mmYDSCH18002024-11-13

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Primary DI, Brand, Company table
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07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
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