Identity
- Trade Name
- Pure Comfort Prostate Patch FDA UDI
- Generic Name
- Moist-heat pack FDA UDI
- Device Name
- Pure Comfort Prostate Patch FDA UDI
- Model / Reference
- 7928 FDA UDI
- Description
- Pure Comfort Prostate Patch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850632007928 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Moist-heat pack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Moist-heat pack
Pure Comfort Prostate Patch by Home Aide Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- COLLINS SPORTS — Asp Global, LLC · Class I
- HydraHeat — COMPASS HEALTH BRANDS CORP. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI b02bca01-16f8-4993-bc4d-167eeca3890e 34 fields · synced Jun 1, 2026