FDA.reportPublic FDA data

Norav 1200 Series PC-ECG

Primary DI
04260498566976
Brand
Norav 1200 Series PC-ECG
Company
Norav Medical GmbH
Model
L10-S-E-W-L1-07
Catalog number
L10-S-E-W-L1-07
Device description
ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, IEC color coding
Published
2020-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260498566976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260498566976042604985669764260498566976

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
341318999
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
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
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
04260498566372Norav MedicalC3-C-E-ODU-08C3-C-E-ODU-082019-12-05

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Primary DI, Brand, Company table
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