FDA.reportPublic FDA data

Vital Signs™

Primary DI
20190752188188
Brand
Vital Signs™
Company
Vyaire Medical Oy
Model
2464AAO-20
Catalog number
2464AAO-20
Device description
Vital Signs™ Leg Attachment Pad
Published
2022-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
20190752188188PackageGS150In Commercial Distribution
10190752188181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019075218818820190752188188
1019075218818110190752188181

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
368457563
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20190752141251Multi-Link™2086367-0032086367-0032021-01-14
20190752141268Multi-Link™2086367-0042086367-0042021-01-14
20190752101729Multi-Link™2086367-0062086367-0062021-01-14
70190752191237Vital Signs™M1031274M10312742023-05-30
50190752117912Vital Signs™7331882019-09-01
50190752117929Vital Signs™7331992019-09-01
50190752117172Vital Signs™73318-HEL2019-09-01
50190752117189Vital Signs™73319-HEL2019-09-01
50190752117493Vital Signs™733062019-09-01
70190752139840AirLife™5570195002019-09-01
70190752139857AirLife™5570701002019-09-01
70190752139864AirLife™5570705002019-09-01
70190752139871AirLife™5570707002019-09-01
70190752139888AirLife™5570715002019-09-01
70190752139895AirLife™5570716002019-09-01
70190752139901AirLife™5570855002019-09-01
70190752139918AirLife™80042312019-09-01
70190752139925AirLife™85702032019-09-01
70190752139932AirLife™M10041322019-09-01
70190752139949AirLife™M10052602019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
08033003267424NAFIAB SPADRX2021-03-31
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08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035283093Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283109Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283123Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20