FDA.reportPublic FDA data

CO-SET+

Primary DI
07460691949997
Brand
CO-SET+
Company
Edwards Lifesciences LLC
Model
93600
Catalog number
93600
Device description
CO-SET DELIVERY SYSTEM FOR COLD INJECTATE
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRBPROBE, THERMODILUTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRBProbe, ThermodilutionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811399000EDSLAB CLOSED INJECTATE DELIVERY SYSTEMAmerican Edwards Laboratories1981-06-09KRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57460691949992PackageGS110In Commercial Distribution
07460691949997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5746069194999257460691949992
07460691949997074606919499977460691949997

GMDN Terms#

Term, Definition table
TermDefinition
Thermal-dilution cardiac output unitA unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

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
Kit
true
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
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08886483551664Safewedge(TM) Relief Valve DeviceBIOPTIMAL INTERNATIONAL PTE. LTD.KRB2026-05-20
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKRB2026-04-15
27325710011144ITS HousingMaquet Critical Care ABKRB2026-03-24
27325710011601PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017047PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017061PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017092PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017108PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710011140ITS HousingMaquet Critical Care ABKRB2026-03-24
07325710011607PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017043PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017067PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017098PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017104PiCCO catheterMaquet Critical Care ABKRB2026-03-24
00690103000078CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
50690103000073CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyKRB2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyKRB2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyKRB2023-04-19
00195278524089NAGE Healthcare Finland OyKRB2023-04-19
00810123205080Adler Instrument CompanyAdler, Inc.KRB2023-03-03
00840682146111CARESCAPE B650GE Healthcare Finland OyKRB2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyKRB2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyKRB2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
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00840619043636ICU MedicalICU MEDICAL, INC.KRB2021-10-19