FDA.reportPublic FDA data

Holter down load and review software. Includes download device according to reco

Primary DI
07290110252687
Brand
Holter down load and review software. Includes download device according to reco
Company
NORAV MEDICAL LTD.
Model
SOFT-NH300-1
Catalog number
HASP-SW-K-NH300-1-01
Device description
Holter down load and review software. Includes download device according to reco
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07290110252687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110252687072901102526877290110252687

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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

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07290110254780Norav NR SeriesNR1207-E KitNR1207E-K-00-E-B10-022019-10-01
07290110254810Norav NR SeriesNR1207-E KitNR1207E-K-00-E-S10-012019-10-01
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07290110255206Norav NR SeriesNR1207-E KitNR1207E-K-00-E-012019-10-01
07290110255213Norav NR SeriesNR1207-3 KitNR12073-K-00-E-012019-10-01
07290110255343Norav NR SeriesNR1207-3 KitNR12073-K-00-E-022019-10-01
07290110255404Norav NR SeriesNR1207-E KitNR1207E-K-00-E-B10-062019-10-01
07290110253035Norav NR SeriesNR302NR302-D-00E-012019-09-30
07290110253042Norav NR SeriesNR302 KitNR302-K-00-E-S7-012019-09-30
07290110253059Norav NR SeriesNR314NR314-D-00E-012019-09-30

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