Identity
- Trade Name
- Comfort Shield Adult Underpads FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- • 150 underpads per box • Size: 30in x 36in • 28" wide pad • 60 grams of padding • 24" of padded protection • Extra absorbent underpads for incontinence • Provides excellent protection for beds and chairs • Absorbs well to prevent leakage • Reduces odors and maintains dryness FDA UDI
- Model / Reference
- 1539 FDA UDI
- Description
- • 150 underpads per box • Size: 30in x 36in • 28" wide pad • 60 grams of padding • 24" of padded protection • Extra absorbent underpads for incontinence • Provides excellent protection for beds and chairs • Absorbs well to prevent leakage • Reduces odors and maintains dryness FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00891237001539 FDA UDI
- FDA Product Code
- KME FDA UDI
- GMDN Term
- General surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: General surgical procedure kit, non-medicated, single-use
Comfort Shield Adult Underpads by Home Aide Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 44e86b80-ff45-4874-b48b-200c96c7ec97 34 fields · synced May 31, 2026