FDA.reportPublic FDA data

Series 8 Anacom MedTek

Primary DI
00812324018377
Brand
Series 8 Anacom MedTek
Company
Anacom Medtek
Model
A1604-128DJM
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
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

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
00812324018377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324018377008123240183778123240183770812324018377

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00812324018513Series 8 Anacom MedTekA1809-088DJ2026-09-30

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
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
00840828196772RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08