FDA.reportPublic FDA data

Bittium OmegaSnap

Primary DI
06430035220670
Brand
Bittium OmegaSnap
Company
Bittium Biosignals Oy
Model
2-CH ECG Electrode
Catalog number
9404716
Device description
2-CH ECG Electrode
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035220670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035220670064300352206706430035220670

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
369960000
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035220311Faros 360 waterproofFaros 3609011592018-04-30
06430035220014FemiScanHTCS-22016-09-22
06430035220021FemiScanCover2016-09-22
06430035220199ME6000ME6000 4ch2016-09-22
06430035220205ME6000ME6000 8ch2016-09-22
06430035220212ME6000ME6000 16ch2016-09-22
06430035220236ME6000ME6000 4ch WLAN2016-09-22
06430035220243ME6000ME6000 8ch WLAN2016-09-22
06430035220229eMotion ECGeMotion ECG sensor2016-09-22
06430035220328Bittium Faros 180 waterproofFaros 1802021-12-17
06430035220519Bittium OmegaSnap 1-CH ECG Electrode9404644 2021-12-17
06430035220588Bittium OmegaSnap 1-CH Adapter94001472021-12-17
06430035220687Bittium OmegaSnap 3-CH ECG Electrode94047172021-12-17
06430035220694Bittium OmegaSnap 1-CH ECG Electrode 94047182021-12-17
06430035220700Bittium OmegaSnap Multi-CH Adapter94047192021-12-17
06430035220151FarosFaros 902016-09-22
06430035220168FarosFaros 1802016-09-22
06430035220366Bittium FarosFaros 14d2019-10-23
06430035220175FarosFaros 3602016-09-22
06430035220335Fast-Fix ECG Electrode9011552018-07-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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