FDA.reportPublic FDA data

Prefense

Primary DI
00851725007214
Brand
Prefense
Company
Nihon Kohden Digital Health Solutions, LLC
Model
EDNS-9001-AVGH977
Catalog number
EDNS-9001-AVGH977
Device description
Prefense - Early Detection and Notification System (Vital Signs Central) PC
Published
2020-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851725007214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851725007214008517250072148517250072140851725007214

GMDN Terms#

Term, Definition table
TermDefinition
Centralized patient monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify0050°C non-condensing
Storage Environment Humidity80 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)474-9207info@nklab.com

Regulatory Flags#

DUNS number
126381560
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851725007368NetKonnect CentralNKCNS-0012026-03-31
00851725007399Central StationCNSCS-0012025-06-30
00851725007351Next Generation NetKonnectNGNK-6801NGNK-68012023-06-05
00851725007115Next Generation NetKonnectNGNK-6803-MNGNK-6803-M2022-08-31
00851725007306Next Generation NetKonnectNGNK-6803NGNK-68032022-08-31
00851725007313Next Generation NetKonnectNGNK-6804NGNK-68042022-08-31
00851725007320Next Generation NetKonnectNGNK-6803-TNGNK-6803-T2022-08-31
00851725007337Next Generation NetKonnectNGNK-6804-MNGNK-6804-M2022-08-31
00851725007344Next Generation NetKonnectNGNK-6804-TNGNK-6804-T2022-08-31
00851725007269Remote Network StationRNS-6804-7490-URNS-6804-7490-U2021-09-30
00851725007276Remote Network StationRNS-6803-7490-URNS-6803-7490-U2021-09-30
00851725007283Remote Network StationRNS-6804-7490RNS-6804-74902021-09-30
00851725007290Remote Network StationRNS-6803-7490RNS-6803-74902021-09-30
00851725007245Remote Network StationRNS-6804-7480-URNS-6804-7480-U2021-05-26
00851725007252Remote Network StationRNS-6803-7480-URNS-6803-7480-U2021-05-26
00851725007221Remote Network StationRNS-6804-7480RNS-6804-74802020-12-23
00851725007238Remote Network StationRNS-6803-7480RNS-6803-74802020-12-23
00851725007177Remote Network StationRNS-6804-7460RNS-6804-74602020-03-25
00851725007184Remote Network StationRNS-6803-7460RNS-6803-74602020-03-25
00851725007191Remote Network StationRNS-6803-7470RNS-6803-74702020-03-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
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04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
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00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
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00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
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