Identity
- Trade Name
- HANDHELD PENDANT,800,30,N,L1,L2,RW FDA UDI
- Generic Name
- Pillow speaker FDA UDI
- Device Name
- HANDHELD PENDANT,800,30,N,L1,L2,RW FDA UDI
- Model / Reference
- HHP800-047 FDA UDI
- Description
- HANDHELD PENDANT,800,30,N,L1,L2,RW FDA UDI
Identifiers
- Catalog Number
- 18542 FDA UDI
- Primary DI / UDI-DI
- 00840828139083 FDA UDI
- FDA Product Code
- IQA FDA UDI
- GMDN Term
- Pillow speaker FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3725 FDA UDI
- Commercial Distribution
- Not 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
No
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
Handheld Pendant, 800, 30, N, L1, L2, Rw by Curbell Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 257cda4a-6370-40fa-ade1-69e70bade072 36 fields · synced May 30, 2026