FDA.reportPublic FDA data

AIPHONE

Primary DI
00790143055554
Brand
AIPHONE
Company
AIPHONE CO., LTD.
Model
NHR-4A/A.E
Device description
The dual bulb corridor lamp of the nurse call intercom
Published
2017-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00790143055554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00790143055554007901430555547901430555540790143055554

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690595012
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00790143054038AIPHONENHX-30G2017-12-08
00790143054144AIPHONENHX-50M.E2017-12-08
00790143054250AIPHONENHX-80X.E2017-12-08
00790143054588AIPHONENHR-30K.E2017-12-08
00790143054694AIPHONENHR-SP.E2017-12-08
00790143054700AIPHONENHR-3TS.E2017-12-08
00790143054816AIPHONENH-1SA/A.E2017-12-08
00790143054922AIPHONENH-2SA/A.E2017-12-08
00790143055776AIPHONENHR-8C.E2017-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812664024564TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-09-30
B4849916DXYY0DuraCall Call Cord for Tektone Tek-CARE300III, Dual, 8pin DINCrest Healthcare SupplyIQA2026-09-29
00812664020047TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-26
00812664024557TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664024779TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664024939TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
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
00812664025141TekTone 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