FDA.reportPublic FDA data

Multi-Link™

Primary DI
10889483578087
Brand
Multi-Link™
Company
AirLife Finland Oy
Model
2090101-922
Catalog number
2090101-922
Device description
Multi-Link™ X2 Single-Patient-Use Direct-Connect ECG Leadwire Set 5-Lead Set for Dräger, Snap, AHA
Published
2025-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200510000Multi-LinkTM X2 ECG Adapter and LeadwiresVyaire Medical, Inc.2020-10-09DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483578084PackageGS110In Commercial Distribution
10190752182820PreviousGS10
10889483578087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948357808420889483578084
1019075218282010190752182820
1088948357808710889483578087

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
368457563
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752139749AirLife™85702302019-09-01
10889483590591AirLife™857023085702302025-04-02
10190752140912Vital Signs™M1031274M10312742021-01-28
10190752145641Vital Signs™M1031273M10312732021-07-06
10190752191235Vital Signs™M1031274M10312742023-05-30
10190752125582Vital Signs™2025248-0012025248-0012018-11-23
10190752125599Vital Signs™2025248-0022025248-0022018-11-23
10190752125629Vital Signs™9446-9119446-9112018-11-23
10190752125636Vital Signs™9446-9139446-9132018-11-23
10190752181380Vital Signs™9446-9119446-9112020-12-15
10190752181397Vital Signs™9446-9139446-9132020-12-15
10190752179349Vital Signs™2025248-0012025248-0012020-12-01
10190752179356Vital Signs™2025248-0022025248-0022020-12-01
10889483587881AirLife™6600-0196-7006600-0196-7002025-03-26
10889483587904AirLife™6600-0208-7006600-0208-7002025-03-26
10889483590003AirLife™800423180042312025-04-02
10889483590584AirLife™857020385702032025-04-02
10889483601563AirLife™M1010534M10105342025-04-02
10889483602522AirLife™M1038637M10386372025-03-31
10889483603222Vital Signs™M1138830M11388302025-04-02

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Primary DI, Brand, Company table
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04048675746768Temp adapter Jack Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
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