FDA UDI
In Commercial Distribution
🇺🇸 United States
WaterPik Promax Waterflosser 6PK
DI: 10073950337240
·
Model: 20033724
·
WATER PIK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WaterPik Promax Waterflosser 6PK
- Primary DI
- 10073950337240
- Version / Model
- 20033724
- Catalog Number
- WF-23
- Company Name
- WATER PIK, INC.
- Labeler DUNS
- 001804074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-09
- Public Version
- 1
- Public Version Date
- 2025-12-17
- Public Version Status
- New
- Public Device Record Key
- ee3b4a61-2e86-4544-b465-2279d9b1c923
Device Description
Countertop Waterflosser, White
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFS | Unit, Oral Irrigation | Dental | 872.6510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63584 | Water jet flosser/sonic electric toothbrush | An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece, and to provide (sonic) vibration for toothbrush heads attached to the handpiece for brushing the teeth. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10073950337240 | GS1 |
Customer Contacts
- Phone
- 1-800-525-2774
- [email protected]