FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 00197344199764
·
Model: MDS136200
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 00197344199764
- Version / Model
- MDS136200
- Catalog Number
- MDS136200
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-06
- Public Version
- 1
- Public Version Date
- 2026-03-16
- Public Version Status
- New
- Public Device Record Key
- f82dff87-3fee-4461-808a-84377f4eb40b
Device Description
DENTAL WATER JET, RECHARGEABLE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 63585 | Water jet flosser | 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. 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 |
|---|---|---|---|---|---|---|
| Package | 10197344199761 | GS1 | CS | 30 | In Commercial Distribution | |
| Primary | 00197344199764 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry; Protect from freezing, Avoid excessive heat