FDA.reportPublic FDA data

TekTone Sound & Signal Mfg., Inc.

Primary DI
00812664025141
Brand
TekTone Sound & Signal Mfg., Inc.
Company
TEKTONE SOUND AND SIGNAL, MFG., INC.
Model
PM334Z
Device description
ZONE CONTROLLER, TC3000/GEN3
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812664025148PackageGS130In Commercial Distribution
00812664025141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081266402514810812664025148
00812664025141008126640251418126640251410812664025141

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call systemAn assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.

Regulatory Flags#

DUNS number
066937301
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00812664025127TekTone Sound & Signal Mfg., Inc.LI494G32026-08-19
00812664024700TekTone Sound & Signal Mfg., Inc.IR3302026-08-18
00812664024717TekTone Sound & Signal Mfg., Inc.IR3312026-08-18
00812664024724TekTone Sound & Signal Mfg., Inc.IR3322026-08-18
00812664024731TekTone Sound & Signal Mfg., Inc.IR434G32026-08-18
00812664024892TekTone Sound & Signal Mfg., Inc.IR430G32026-08-18
00812664024908TekTone Sound & Signal Mfg., Inc.IR431G32026-08-18
00812664024915TekTone Sound & Signal Mfg., Inc.IR432G32026-08-18
00812664025134TekTone Sound & Signal Mfg., Inc.LI334Z2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812664025127TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-19
00812664024700TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024717TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024724TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024731TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024892TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024908TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024915TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025134TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00840828197007GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-08-18
00840828196864GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196871GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196758GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196789GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196796GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196802GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196819GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196826GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196833GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196840GEN4 DIGITALCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196666GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196673GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196475GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196482GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196499GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196505GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196512GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196529GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196536GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196543GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27