FDA.reportPublic FDA data

Multi-Link™

Primary DI
10889483578308
Brand
Multi-Link™
Company
AirLife Finland Oy
Model
2090600-038
Catalog number
2090600-038
Device description
ML X2 ECG Reusable Trunk Cable, 3-lead for Physio Control, AHA, 360cm/12ft
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K162432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162432000Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc.2017-01-18DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752178496PreviousGS10
10889483578308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075217849610190752178496
1088948357830810889483578308

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
10190752110588Vital Signs™2013066-0042013066-0042020-11-27
10190752110595Vital Signs™2013066-0052013066-0052020-11-27
10190752110601Vital Signs™2013066-0072013066-0072020-11-27
10190752110632Vital Signs™2013067-0032013067-0032020-11-27
10190752110649Vital Signs™2013067-0042013067-0042020-11-27
10190752110656Vital Signs™2013068-0012013068-0012020-11-27
10190752110663Vital Signs™2013068-0022013068-0022020-11-27
10190752110670Vital Signs™2013068-0032013068-0032020-11-27
10190752110687Vital Signs™2013068-0042013068-0042020-11-27
10190752110755Vital Signs™415036-001415036-0012020-11-27
10190752110762Vital Signs™415036-002415036-0022020-11-27
10190752140882Vital Signs™900604-003900604-0032021-01-28
10190752140899Vital Signs™900604-004900604-0042021-01-28
10190752140905Vital Signs™900604-005900604-0052021-01-28
10889483581223Vital Signs™38401809384018092025-04-02
10190752112926Vital Signs™38401809384018092018-11-23
10190752179981Vital Signs™38401809384018092020-12-17
10190752110724Vital Signs™412341-001412341-0012020-11-27
10190752139749AirLife™85702302019-09-01
10889483590591AirLife™857023085702302025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607451FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607468FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607475FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607482FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
06944413830585ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830592ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830608ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830615ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830622ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830639ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830646ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830653ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830660ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830677ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830684ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830691ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830707ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830714ECG CableEdan Instruments, Inc.DSA2026-11-02
G662ME550W1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028G1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028J1MaguireMaguire Enterprises, Inc.DSA2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19