FDA.report

Multi-Link™

Primary DI
20190752179544
Brand
Multi-Link™
Company
Vyaire Medical Oy
Model
2052133-005
Catalog number
2052133-005
Device description
Single-Patient-Use ECG Leadwire Set 3-LEAD, GRABBER, AHA, 100 cm/39 in
Published
2020-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications

CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20190752179544PackageGS110In Commercial Distribution
10190752141094PreviousGS10
10190752179547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019075217954420190752179544
1019075214109410190752141094
1019075217954710190752179547

GMDN Terms

TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, 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 to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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 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

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