FDA.reportPublic FDA data

Norav 1200 Series PC-ECG

Primary DI
04260498566921
Brand
Norav 1200 Series PC-ECG
Company
Norav Medical GmbH
Model
1200W Kit
Catalog number
1200W2-K-04-U-C10-03
Device description
Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads AHA type and Clip connectors.Special edition for GE Health Care.
Published
2020-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260498566921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260498566921042604985669214260498566921

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic signal amplifierAn electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4961345679830info@norav.com

Regulatory Flags#

DUNS number
341318999
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
04260498564057Norav 1200 Series PC-ECGC10-C-E-D-10k-03C10-C-E-D-10k-032023-02-18
04260498566969Norav 1200 Series PC-ECGL10-S-U-W-L1-07L10-S-U-W-L1-072020-07-09
04260498566976Norav 1200 Series PC-ECGL10-S-E-W-L1-07L10-S-E-W-L1-072020-07-09
04260498566983Norav 1200 Series PC-ECGL10-C-E-W-L1-07L10-C-E-W-L1-072020-07-09
04260498566990Norav 1200 Series PC-ECGL10-C-U-W-L1-07L10-C-U-W-L1-072020-07-09
04260498566792Norav MedicalC3-C-U-LL-D-FUC3-C-U-LL-D-FU2020-01-03
04260498566785Norav ECG Input CableLC1-C-E-W-07LC1-C-E-W-072019-12-14
04260498566945Norav ECG Input CableLC1-S-E-W-07LC1-S-E-W-072019-12-14
04260498563074Norav MedicalC3-C-U-LL-DC3-C-U-LL-D2019-12-05
04260498565948Norav MedicalC3-C-U-LL-ODURC3-C-U-LL-ODUR2019-12-05
04260498565955Norav MedicalC3-ODU-EXC3-ODU-EX2019-12-05
04260498565993Norav MedicalC3-C-U-LL-ODUR-WC3-C-U-LL-ODUR-W2019-12-05
04260498566006Norav MedicalC3-ODU-EX-VC3-ODU-EX-V2019-12-05
04260498566105Norav MedicalC3-C-LL-ODU-VC3-C-LL-ODU-V2019-12-05
04260498566242Norav MedicalL10-C-E-W-07L10-C-E-W-072019-12-05
04260498566259Norav MedicalL10-C-U-W-07L10-C-U-W-072019-12-05
04260498566266Norav MedicalC3-C-U-ODU-07C3-C-U-ODU-072019-12-05
04260498566303Norav MedicalL10-S-U-W-07L10-S-U-W-072019-12-05
04260498566358Norav MedicalC3-C-E-ODU-07C3-C-E-ODU-072019-12-05
04260498566365Norav MedicalL10-S-E-W-07L10-S-E-W-072019-12-05

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