FDA.reportPublic FDA data

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

Primary DI
00690103197181
Brand
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Company
Edwards Lifesciences LLC
Model
XA3816SAFKT
Catalog number
XA3816SAFKT
Device description
EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECATHETER, OXIMETER, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160645000PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC2016-06-16DQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103197181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103197181006901031971816901031971810690103197181

GMDN Terms#

Term, Definition table
TermDefinition
Oximeter catheter, single-useA flexible tube containing a fibreoptic bundle designed to conduct light at a selected wavelength through blood to detect the reflected or scattered light for the estimation of blood oxygen concentration. It detects with a sensor at its distal end and is used in conjunction with an oximeter for oxygen concentration calculation. This device is also known as a Swan-Ganz catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDQE2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
50690103218621SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000412SWAN-GANZEdwards Lifesciences LLCDQE2026-01-30
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCDQE2025-09-10
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00690103219616ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDQE2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDQE2025-07-11
50690103219611ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
10889483591420Vital Signs™AirLife Finland OyDQE2025-04-02
10889483591437Vital Signs™AirLife Finland OyDQE2025-04-02
00840619046613ICU MedicalICU MEDICAL, INC.DQE2025-03-25
10840619046610ICU MedicalICU MEDICAL, INC.DQE2025-03-25
00690103217957HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103219371SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
50690103219376SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103218879HemoSphere VitaEdwards Lifesciences LLCDQE2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDQE2024-08-28
00690103219388SWAN-GANZEdwards Lifesciences LLCDQE2024-08-05
50690103219383SWAN-GANZEdwards Lifesciences LLCDQE2024-08-05
00690103217124HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26