FDA.reportPublic FDA data

Multi-Link™

Primary DI
20889483578084
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.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
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
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
04048675379300IBP Cable UtahDrägerwerk AG & Co. KGaADSA2026-01-07
04048675557722IBP Adapter Cable Dräger 7pinDrägerwerk AG & Co. KGaADSA2026-01-07
04048675379072IBP cable Becton DickinsonDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379089IBP Cable Abbott, MedexDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379096IBP cable EdwardsDrägerwerk AG & Co. KGaADSA2026-01-06
04048675557739IBP Adapter Cable Drager 10pinDrägerwerk AG & Co. KGaADSA2026-01-06
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08