FDA.reportPublic FDA data

Multi-Link™

Primary DI
10190752180048
Brand
Multi-Link™
Company
Vyaire Medical Oy
Model
403751-024
Catalog number
403751-024
Device description
ECG Leadwire, Radiolucent 12-lead, Grabber, AHA, 150 cm/59 in
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752106468PreviousGS10
10190752180048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075210646810190752106468
1019075218004810190752180048

GMDN Terms#

Term, Definition table
TermDefinition
Radiolucent electrocardiographic leadA radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-22 Degrees Fahrenheit140 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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10190752106536Multi-Link™411200-001411200-0012018-11-23
10190752106543Multi-Link™411200-002411200-0022018-11-23
10190752106574Multi-Link™411200-005411200-0052018-11-23
10190752106581Multi-Link™411202-001411202-0012018-11-23
10190752106598Multi-Link™411202-002411202-0022018-11-23
10190752106628Multi-Link™411202-005411202-0052018-11-23
10190752106642Multi-Link™411203-001411203-0012018-11-23
10190752106659Multi-Link™411203-002411203-0022018-11-23
10190752106680Multi-Link™412681-001412681-0012018-11-23
10190752106697Multi-Link™412681-002412681-0022018-11-23
10190752106741Multi-Link™412682-001412682-0012018-11-23
10190752106758Multi-Link™412682-002412682-0022018-11-23
10190752106789Multi-Link™414556-001414556-0012018-11-23
10190752106796Multi-Link™414556-002414556-0022018-11-23
10190752106826Multi-Link™414556-005414556-0052018-11-23
10190752106840Multi-Link™416467-001416467-0012018-11-23
10190752106864Multi-Link™416467-003416467-0032018-11-23
10190752106888Multi-Link™416468-001416468-0012018-11-23
10190752106901Multi-Link™416468-003416468-0032018-11-23
10190752106925Multi-Link™421930-001421930-0012018-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationDSA2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationDSA2026-05-26
07613365003925SCHILLERSchiller AGDSA2026-05-26
07613365003932SCHILLERSchiller AGDSA2026-05-26
07613365003949SCHILLERSchiller AGDSA2026-05-26
07613365003956SCHILLERSchiller AGDSA2026-05-26
07613365004199SCHILLERSchiller AGDSA2026-05-26
07613365004205SCHILLERSchiller AGDSA2026-05-26
07613365004212SCHILLERSchiller AGDSA2026-05-26
07613365004229SCHILLERSchiller AGDSA2026-05-26
10653405063797CONMEDConmed CorporationDSA2026-03-24
20653405017766CONMEDConmed CorporationDSA2026-03-24
20653405019777CONMEDConmed CorporationDSA2026-03-24
20653405022821CONMEDConmed CorporationDSA2026-03-24
20653405022838CONMEDConmed CorporationDSA2026-03-24
20653405022951CONMEDConmed CorporationDSA2026-03-24
20653405023057CONMEDConmed CorporationDSA2026-03-24
20653405023071CONMEDConmed CorporationDSA2026-03-24
20653405023163CONMEDConmed CorporationDSA2026-03-24
20653405023170CONMEDConmed CorporationDSA2026-03-24
20653405023385CONMEDConmed CorporationDSA2026-03-24
20653405023545CONMEDConmed CorporationDSA2026-03-24
20653405034701CONMEDConmed CorporationDSA2026-03-24
20653405036194CONMEDConmed CorporationDSA2026-03-24
20653405059858CONMEDConmed CorporationDSA2026-03-24
G662ME590132J1MaguireMaguire Enterprises, Inc.DSA2026-03-20
00884838117433NOUNPhilips Medizin Systeme Böblingen GmbHDSA2026-03-19
00840416606676FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-03-16
00840416606683FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-03-16
00840416606690FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-03-16