FDA.reportPublic FDA data

Fast-Fix ECG Electrode

Primary DI
06430035220335
Brand
Fast-Fix ECG Electrode
Company
Bittium Biosignals Oy
Model
901155
Device description
The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's chest, and it transfers the hearts biosignal from the body to the Faros ECG device.
Published
2018-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
06430035220335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035220335064300352203356430035220335

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

Contacts#

Phone, Email table
PhoneEmail
+358400541179bbs@bittium.com

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
06430035220670Bittium OmegaSnap 2-CH ECG Electrode94047162021-12-17
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

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G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
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08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
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