FDA.reportPublic FDA data

Holter analysis software + Data base. Includes download device according to reco

Primary DI
07290110252724
Brand
Holter analysis software + Data base. Includes download device according to reco
Company
NORAV MEDICAL LTD.
Model
SOFT-NH300-3
Published
2016-10-26
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
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110252724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110252724072901102527247290110252724

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97249893001info@norav.com

Regulatory Flags#

DUNS number
514773159
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110255367Norav 1200 Series PC-ECG1200WR1200WR-D-00-072019-09-27
07290110250591Receiver for 1200W with ECG trigger (TTL) outputPCECG 1200WR1200WR-D-00-012016-10-26
07290110251192Telemetry System. License + Software for up to 7 usersNM-700BT2017-01-03
07290110255008Norav 1200 Series PC-ECGSW P-MP200HASP-SW-K-P1-012019-10-02
07290110252502Norav 1200 Series PC-ECGECGLAN Green PCLAN-GREEN-PC-012019-09-30
07290110252519"ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3"" prin"ECG-LAN (Green)ECG-LAN-GREEN-K-00-012017-01-03
07290110251062ECG ECGUSB1D-EX-FW11/BECG Module2016-10-13
07290110255558Norav 1200 Series PC-ECGECGUSB1DEX KitECGUSB1DEX-K-00-UC3-082020-06-05
07290110255572Norav 1200 Series PC-ECGECGUSB1DEXECGUSB1DEX-D-00-102020-06-05
07290110255589Norav 1200 Series PC-ECGECGUSB1DEX KitECGUSB1DEX-K-00-EC3-102020-06-05
07290110255480Norav 1200 Series PC-ECG1200HRT Kit1200HRT-K-00-U-S10-032020-06-03
07290110255497Norav 1200 Series PC-ECG1200HRT1200HRT-D-00U-032020-06-03
07290110255411Norav 1200 Series PC-ECGSW I3HASP-SW-K-I3-012019-10-11
07290110252762Norav 1200 Series PC-ECGSW S1HASP-SW-K-S1-012019-10-02
07290110252779Norav 1200 Series PC-ECGSW S2HASP-SW-K-S2-012019-10-02
07290110252786Norav 1200 Series PC-ECGSW S2toS2HASP-SW-K-S2-S1-012019-10-02
07290110252793Norav 1200 Series PC-ECGSW S2-I1HASP-SW-K-S2I1-012019-10-02
07290110252809Norav 1200 Series PC-ECGSW S2-I1-D1HASP-SW-K-S2I1D1-012019-10-02
07290110252816Norav 1200 Series PC-ECGSW S2-I3-D1HASP-SW-K-S2I3D1-012019-10-02
07290110255022Norav 1200 Series PC-ECGSW S2-I2HASP-SW-K-S2I2-012019-10-02

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00732094345643Welch Allyn, Inc.WELCH ALLYN, INC.MLO2021-02-10
00841709118067MIDMARK IQHOLTER® PLUG-IN SOFTWAREMIDMARK CORPORATIONMLO2020-12-28
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B146ERWCD030ER9W CDMA UNMBRAEMAR MANUFACTURING, LLCMLO2020-07-15
00817111021172Polysmith Version 12.0Neurotronics, LLCMLO2020-04-01
00732094263978Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-03-24
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