FDA.reportPublic FDA data

NA

Primary DI
00690103002614
Brand
NA
Company
Edwards Lifesciences LLC
Model
70ANH
Catalog number
70ANH
Device description
CABLE,SLAVE F/VIGILANCE N/S
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043103000VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2Edwards Lifesciences, LLC2004-12-09DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103002614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103002614006901030026146901030026140690103002614

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Feet

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864609000348VitalStream ART Connect; VitalStream Hemo; ART DockCARETAKER MEDICAL, LLCDXG2026-06-02
00850044487042Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487103Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
00198953066560NAGE Healthcare Finland OyDXG2026-01-05
07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
27290013030041StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
47290013030045StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
07290013030047StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
77290013030046StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDXG2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDXG2023-04-19
00195278524089NAGE Healthcare Finland OyDXG2023-04-19
00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09