FDA.reportPublic FDA data

Vital Signs

Primary DI
10885403257384
Brand
Vital Signs
Company
Carefusion Finland 320 Oy
Model
8001959-HEL
Catalog number
8001959-HEL
Device description
300-Series ECG Leadwire, 5-lead, Grabber, AHA, 150 cm/ 59 in
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLDMONITOR, ST SEGMENT WITH ALARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLDMonitor, St Segment With AlarmCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403257384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540325738410885403257384

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of 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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
367919120
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403252051Multi-Link2052104-0052052104-0052016-09-14
10885403252068Multi-Link2052104-0062052104-0062016-09-14
10885403252075Multi-Link2052104-0072052104-0072016-09-14
10885403252082Multi-Link2052104-0082052104-0082016-09-14
10885403252112Multi-Link2052133-0052052133-0052016-09-14
10885403252129Multi-Link2052133-0062052133-0062016-09-14
10885403252136Multi-Link2052133-0072052133-0072016-09-14
10885403252143Multi-Link2052133-0082052133-0082016-09-14
10885403256837Multi-Link2086349-0032086349-0032016-09-14
10885403256844Multi-Link2086349-0042086349-0042016-09-14
10885403256875Multi-Link2086367-0032086367-0032016-09-14
10885403256882Multi-Link2086367-0042086367-0042016-09-14
10885403417436Multi-Link2052104-0272052104-0272016-09-14
10885403417450Multi-Link2052133-0272052133-0272016-09-14
10190752100015Multi-Link™2090101-0502090101-0502017-07-11
10190752100022Multi-Link™2090101-0602090101-0602017-07-11
10190752100046Multi-Link™2090101-0802090101-0802017-07-11
10190752100084Multi-Link™2090101-5112090101-5112017-07-11
10190752100107Multi-Link™2090101-5122090101-5122017-07-11
10190752100121Multi-Link™2090101-5132090101-5132017-07-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMLD2026-04-15
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-03-09
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-11-17
06944413838406Patient Monitor Edan Instruments, Inc.MLD2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.MLD2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-05-06
00850067829003LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829010LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829027LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829041LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829058LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829065LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829072LIFEECaf Medical Solutions, IncMLD2025-02-12
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgMLD2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgMLD2024-11-27
06944413815889Patient MonitorEdan Instruments, Inc.MLD2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.MLD2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.MLD2024-06-17
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMLD2024-06-07