FDA UDI
In Commercial Distribution
🇺🇸 United States
Wellness
DI: 00819835024125
·
Model: Wellness - Kegel Training Kit - Purple
·
Blush Novelties
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Wellness
- Primary DI
- 00819835024125
- Version / Model
- Wellness - Kegel Training Kit - Purple
- Catalog Number
- BL-444004
- Company Name
- Blush Novelties
- Labeler DUNS
- 057027601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-28
- Public Version
- 1
- Public Version Date
- 2025-02-05
- Public Version Status
- New
- Public Device Record Key
- 2dacd3b7-3802-45d5-a589-99d7e3c4d80b
Device Description
Wellness - Kegel Training Kit - Purple Part Number: BL-444004 Material: Silicone
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
- Yes
- 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 |
|---|---|---|---|---|
| HIR | Perineometer | Obstetrics/Gynecology | 884.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32686 | Perineometer | A device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819835024125 | GS1 |