FDA.reportPublic FDA data

PRESEP

Primary DI
00690103176810
Brand
PRESEP
Company
Edwards Lifesciences LLC
Model
X3816S
Catalog number
X3816S
Device description
PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOSHIELD
Published
2016-09-03
Public version status
Update
Distribution status
Not 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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053609000
K110167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053609000PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOREdwards Lifesciences, LLC2006-02-28DQE
K110167000PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLC2011-02-18DQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103176810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103176810006901031768106901031768100690103176810

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103222456AUTUS Size Adjustable ValveAUT001AUT0012026-10-30
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

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00884450499245Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499870Merit S-MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-29
10884450708443Prelude®Merit Medical Systems, Inc.DRE2026-10-29
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-20
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