FDA.reportPublic FDA data

Series 8 Anacom MedTek

Primary DI
00812324017318
Brand
Series 8 Anacom MedTek
Company
Anacom Medtek
Model
A1610-088DJ
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
2023-07-12
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
00812324017318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324017318008123240173188123240173180812324017318

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.

Sterilization Methods#

Method table
Method

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
00812324018315Series 8 Anacom MedTekA2945-088DJM2026-09-30
00812324018322Series 7 Anacom MedTekA1400-127.12026-09-30
00812324018339Series 7 Anacom MedTekA4812-087.1J2026-09-30
00812324018346Series 8 Anacom MedTekA1513-128DJ2026-09-30
00812324018353Series 7 Anacom MedTekA1333-087.1D2026-09-30
00812324018360Series 7 Anacom MedTekA1774-087.1J2026-09-30
00812324018377Series 8 Anacom MedTekA1604-128DJM2026-09-30
00812324018384Series 7 Anacom MedTekB2726-087.12026-09-30
00812324018391Series 8 Anacom MedTekB3450-158DJM2026-09-30
00812324018407Series 7 Anacom MedTekB0816-127.12026-09-30
00812324018414Series 8 Anacom MedTekA1818-088DJ2026-09-30
00812324018421Series 8 Anacom MedTekA2944-088DJM2026-09-30
00812324018438Series 8 Anacom MedTekA1883-088DJ2026-09-30
00812324018445Series 8 Anacom MedTekB3483-088DJM2026-09-30
00812324018452Series 8 Anacom MedTekA4032-088DJ2026-09-30
00812324018469Series 8 Anacom MedTekA2946-088DJM2026-09-30
00812324018476Series 8 Anacom MedTekA6065-088DJ2026-09-30
00812324018483Series 8 Anacom MedTekB0810-088DLJ2026-09-30
00812324018490Series 8 Anacom MedTekB3810-088DLJ2026-09-30
00812324018506Series 7 Anacom MedTekA7428-087.1J2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812324018315Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018322Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018339Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018346Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018353Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018360Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018377Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018384Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018391Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018407Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018414Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018421Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018438Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018445Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018452Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018469Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018476Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018483Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018490Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018506Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018513Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00887761943131Voalte Nurse CallHILL-ROM, INC.ILQ2026-09-28
00840828197014RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-08-18
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967274600,R6,BASIC,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967344600,R6,ENH,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196741RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196765RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08