FDA.reportPublic FDA data

Series 8 Anacom MedTek

Primary DI
00812324010494
Brand
Series 8 Anacom MedTek
Company
Anacom Medtek
Model
A5300-088DJ
Device 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.
Published
2023-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812324010494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324010494008123240104948123240104940812324010494

GMDN Terms#

Term, Definition table
TermDefinition
Pillow speakerA loudspeaker intended to be used by a patient when lying in bed or resting in a chair by putting it close to their ear or between a pillow and their ear. It is typically designed as a small pillow-like device that contains a loudspeaker and that has a cable and a connector for connection to a radio, television, or other sound-emitting device with a Jack plug sound outlet. The sound level is regulated by the user with an adjustable control. It is typically used to create a relaxing atmosphere with music, for entertainment (e.g., to listen to the radio), and to aid sleep and relieve tinnitus.

Regulatory Flags#

DUNS number
047785845
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812324018308Series 8 Anacom MedTekA9719-088DJ2026-01-27
00812324018094Series 8 Anacom MedTekA5807-088DJMF022026-01-22
00812324018100Series 7 Anacom MedTekB3814-087.1N2026-01-22
00812324018117Series 8 Anacom MedTekA4878-088DJ2026-01-22
00812324018124Series 8 Anacom MedTekA5808-088DJMF022026-01-22
00812324018131Series 8 Anacom MedTekA6010-128DJ2026-01-22
00812324018148Series 8 Anacom MedTekA6063-128DJ2026-01-22
00812324018155Series 8 Anacom MedTekA5504-088DJ2026-01-22
00812324018162Series 8 Anacom MedTekA1892-088DJ2026-01-22
00812324018179Series 8 Anacom MedTekA6052-008DJ2026-01-22
00812324018186Series 8 Anacom MedTekA1909-088DJ2026-01-22
00812324018193Series 8 Anacom MedTekA2933-008DJM2026-01-22
00812324018209Series 8 Anacom MedTekA2916-088DJM2026-01-22
00812324018216Series 7 Anacom MedTekB5104-087.12026-01-22
00812324018223Series 8 Anacom MedTekB3516-008DJM2026-01-22
00812324018230Series 8 Anacom MedTekB2316-088DJ2026-01-22
00812324018247Series 7 Anacom MedTekA6834-087.1DLJ2026-01-22
00812324018254Series 7 Anacom MedTekA1814-087.12026-01-22
00812324018261Series 7 Anacom MedTekA1814-087.1J2026-01-22
00812324018278Series 8 Anacom MedTekB3515-158dj2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010401Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010418Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010425Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010449Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010456Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010463Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010487Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010586Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010593Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010609Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13