FDA.reportPublic FDA data

SWAN-GANZ

Primary DI
00690103219388
Brand
SWAN-GANZ
Company
Edwards Lifesciences LLC
Model
SGPT755P
Catalog number
SGPT755P
Device description
Swan-Ganz Thermodilution Pediatric
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECatheter, Oximeter, Fiber-Optic
DQOCatheter, Intravascular, Diagnostic
DYGCatheter, Flow Directed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2
DQOCatheter, Intravascular, DiagnosticCardiovascular2
DYGCatheter, Flow DirectedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231248000Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC2023-09-21DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103219383PackageGS15In Commercial Distribution
00690103219388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010321938350690103219383
00690103219388006901032193886901032193880690103219388

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.

Contacts#

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

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220636ESHEATH OPTIMA14000ES16A14000ES162025-10-09
00690103219784Edwards 23F Guide Sheath9880GS9880GSA2026-01-30
00690103219562Edwards EVOQUE Loading System9850LSB9850LSBUS2025-07-09
00690103219579Edwards EVOQUE Stabilizer9850SZUS9850SZUS2025-07-09
00690103220629ESHEATH OPTIMA INTRODUCER SET (14F)14000ES1414000ES142025-05-07
00690103217773Edwards EVOQUE Loading System9850LSAUS9850LSAUS2024-10-03
00690103217483EVOQUE9850PTUS9850PTUS2024-02-07
00690103217490EVOQUE9850LSUS9850LSUS2024-02-07
00690103217506EVOQUE9850DKUS9850DKUS2024-02-07
00690103217513EVOQUE9850SBUS9850SBUS2024-02-07
00690103217476EVOQUE9850BAUS9850BAUS2024-02-06
00690103215465Edwards eSheath+ Introducer set914ESP914ESPA2021-10-06
00690103215472Edwards eSheath+ Introducer set916ESP916ESPA2021-10-06
00690103182262EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T262015-09-24
00690103182279EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T282015-09-24
00690103182286EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T302015-09-24
00690103182293EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T322015-09-24
00690103182309EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T342015-09-24
00690103182316EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T362015-09-24
00690103190816Thruport Systems Introducer Sheath KitIS19AIS19A2016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450836316Performa®Merit Medical Systems, Inc.DQO2026-10-07
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00885403521174SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521525SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521624SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403523437HemoSphere AltaBecton, Dickinson And CompanyDQE2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyDQE2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyDQE2026-08-06
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
10801902208580ARROWTELEFLEX INCORPORATEDDQO2024-02-05
10801902208542ARROWTELEFLEX INCORPORATEDDQO2023-06-12
10801902208559ARROWTELEFLEX INCORPORATEDDQO2023-06-06
10801902192254ARROWTELEFLEX INCORPORATEDDQO2022-11-29
10801902192285ARROWTELEFLEX INCORPORATEDDQO2022-11-08
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
10801902206647ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206715ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902180268ARROWTELEFLEX INCORPORATEDDYG2021-08-19
10801902180756ARROWTELEFLEX INCORPORATEDDYG2021-08-11
07290017268347SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22