Identity
- Trade Name
- Wellness FDA UDI
- Generic Name
- Perineometer FDA UDI
- Device Name
- Wellness - Kegel Training Kit - Purple Part Number: BL-444004 Material: Silicone FDA UDI
- Model / Reference
- Wellness - Kegel Training Kit - Purple FDA UDI
- Description
- Wellness - Kegel Training Kit - Purple Part Number: BL-444004 Material: Silicone FDA UDI
Identifiers
- Catalog Number
- BL-444004 FDA UDI
- Primary DI / UDI-DI
- 00819835024125 FDA UDI
- FDA Product Code
- HIR FDA UDI
- GMDN Term
- Perineometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Perineometer
Wellness by Blush Novelties — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perineometer.
- Leva Pelvic Health System — AXENA HEALTH, INC. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Flyte In-Home Pelvic Floor Treatment — Pelvital USA, Inc. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Pathway® — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Intimina KegelSmart — Leloi AB · Class II
- IVS-2 — PERSONAL MEDICAL CORP. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blush Novelties
Sources (1)
- FDA UDI 2dacd3b7-3802-45d5-a589-99d7e3c4d80b 34 fields · synced May 30, 2026