FDA.reportPublic FDA data

Non-sterile Oral Care Suction Toothbrush

Primary DI
86971092638153
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560446074
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06971092638157Non-sterile Oral Care Suction ToothbrushSuction typeYDAK2025-02-10
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
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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