FDA.reportPublic FDA data

Multi-Link™

Primary DI
10889483578025
Brand
Multi-Link™
Company
AirLife Finland Oy
Model
2090101-821
Catalog number
2090101-821
Device description
Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 3-Lead Set for Nihon Kohden, Snap, AHA
Published
2025-04-02
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
K163316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163316000Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc.2017-06-22DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483578022PackageGS110In Commercial Distribution
10190752182769PreviousGS10
10889483578025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948357802220889483578022
1019075218276910190752182769
1088948357802510889483578025

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24
G662ME5900321MaguireMaguire Enterprises, Inc.DSA2026-07-23
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