FDA.report

Series 8 Anacom MedTek

Primary DI
00812324016014
Brand
Series 8 Anacom MedTek
Company
Anacom Medtek
Model
B3418-088DJ
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
2023-07-14
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

Related Records

Product Codes

CodeName
ILQSystem, Communication, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812324016014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324016014008123240160148123240160140812324016014

GMDN Terms

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

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 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 DIBrandCompanyProduct codePublished
00860014667602MedMinder Systems, Inc.MEDMINDER SYSTEMS, INC.ILQ2026-03-23
00840828196123RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196130RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196147RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196154RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00816486021640PRC-SaltilloPRENTKE ROMICH COMPANYILQ2026-03-10
00840828196093RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-04
00840828196024RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828196048RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195973ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195980ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195997ZEPHYR,800,10,SIP,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195911RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-03
00812324018308Series 8 Anacom MedTekAnacom MedtekILQ2026-01-27
00812324018094Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018100Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018117Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018124Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018131Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018148Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018155Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018162Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018179Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018186Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018193Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018209Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018216Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018223Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018230Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22