FDA UDI
In Commercial Distribution
🇺🇸 United States
Non-sterile Oral Care Suction Toothbrush
DI: 06971092638157
·
Model: Suction type
·
Shijiazhuang Yuanding Medical Device Co., LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- Non-sterile Oral Care Suction Toothbrush
- Primary DI
- 06971092638157
- Version / Model
- Suction type
- Catalog Number
- YDAK
- Company Name
- Shijiazhuang Yuanding Medical Device Co., LTD
- Labeler DUNS
- 560446074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2025-02-10
- Public Version
- 1
- Public Version Date
- 2025-02-18
- Public Version Status
- New
- Public Device Record Key
- 79f53cdf-c8b5-49d2-867b-fc1b40e48677
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66090 | Cannulated manual toothbrush | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86971092638153 | GS1 | ||||
| Primary | 06971092638157 | GS1 | ||||
| Package | 16971092638154 | GS1 | Carton | 30 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store it in a ventilated and dry room without corrosion gas, away from sources of ignition.