Identity
- Trade Name
- 3701,IPS1,08,N,U,VL,LT,AU,SF FDA UDI
- Generic Name
- Pillow speaker FDA UDI
- Device Name
- 3701,IPS1,08,N,U,VL,LT,AU,SF FDA UDI
- Model / Reference
- 33701-440 FDA UDI
- Description
- 3701,IPS1,08,N,U,VL,LT,AU,SF FDA UDI
Identifiers
- Catalog Number
- 546 FDA UDI
- Primary DI / UDI-DI
- 00840828152211 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
- 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
Category: Pillow speaker
3701, Ips1, 08, N, U, Vl, Lt, Au, Sf by Curbell Medical Products, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 1f4b03a8-e949-4d9a-b3d8-6933e3164b11 35 fields · synced Jun 6, 2026