Identity
- Trade Name
- 0412,APS1,08,N,RM,RD,CH FDA UDI
- Generic Name
- Pillow speaker FDA UDI
- Device Name
- 0412,APS1,08,N,RM,RD,CH FDA UDI
- Model / Reference
- 3412-354 FDA UDI
- Description
- 0412,APS1,08,N,RM,RD,CH FDA UDI
Identifiers
- Catalog Number
- 562 FDA UDI
- Primary DI / UDI-DI
- 00840828152303 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Pillow speaker FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
0412, Aps1, 08, N, Rm, Rd, Ch 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 960ec71b-a3cb-4e3a-bbae-709e5a7e4ae3 36 fields · synced Jun 1, 2026