Identity
- Trade Name
- Total Comfort Elbow Support Sleeve LG FDA UDI
- Generic Name
- Tubular support bandage, non-latex, reusable FDA UDI
- Device Name
- Total Comfort Elbow Support Sleeve LG FDA UDI
- Model / Reference
- 4524 FDA UDI
- Description
- Total Comfort Elbow Support Sleeve LG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027494524 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Tubular support bandage, non-latex, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tubular support bandage, non-latex, reusable
Total Comfort Elbow Support Sleeve LG by Home Aide Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tubular support bandage, non-latex, reusable.
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- WALGREENS — WALGREEN CO. · Class I
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- Juzo Suspension Sleeve — JULIUS ZORN, INC. · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · 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 4db2b659-f69f-4422-8a99-1cc35b11dcf2 34 fields · synced May 30, 2026