Identity
- Trade Name
- Series 8 Anacom MedTek FDA UDI
- Generic Name
- Pillow speaker FDA UDI
- Device Name
- A speaker to be used by a patient when lying in bed or resting in a chair. It is a device that contains a speaker and cable and a connector for connection to a radio, television, infotainment or other sound emitting device. It has an audio jack plug for headphones. The sound level is regulated by the user with an adjustable control. FDA UDI
- Model / Reference
- A6051-0.58DJ FDA UDI
- Description
- A speaker to be used by a patient when lying in bed or resting in a chair. It is a device that contains a speaker and cable and a connector for connection to a radio, television, infotainment or other sound emitting device. It has an audio jack plug for headphones. The sound level is regulated by the user with an adjustable control. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812324015734 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
Yes
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
Category: Pillow speaker
Series 8 Anacom MedTek by Anacom Medtek — 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
- Anacom Medtek
Sources (1)
- FDA UDI ef4cae0d-8be8-4c0e-b1f7-1ea0e6f2170f 33 fields · synced May 31, 2026