Identity
- Trade Name
- MEDI FDA UDI
- Generic Name
- Compression/pressure sock/stocking, single-use FDA UDI
- Device Name
- ***DISC*20-30 MEDIVEN HARMONY GAUNTLET S FDA UDI
- Model / Reference
- 2Y20802 FDA UDI
- Description
- ***DISC*20-30 MEDIVEN HARMONY GAUNTLET S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04051526560680 FDA UDI
- FDA Product Code
- DWL FDA UDI
- GMDN Term
- Compression/pressure sock/stocking, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5780 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
A comprehensive 2-3 paragraph SEO description written in clear, natural language. This device is a garment intended for the treatment/prevention of disorders of circulation, specifically venous insufficiency and deep vein thrombosis (DVT). It applies compression/pressure to the leg and foot through a sock or stocking design.
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 |
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Manufacturer
- Manufacturer
- Medi Manufacturing, Inc.
Sources (1)
- FDA UDI 32fb8068-d72b-4dea-b92a-e83d89710409 35 fields · synced Jul 9, 2026