FDA.reportPublic FDA data

FloTrac IQ

Primary DI
00690103197778
Brand
FloTrac IQ
Company
Edwards Lifesciences LLC
Model
MHDQ85
Catalog number
MHDQ85
Device description
FloTrac IQ sensor (five pack)
Published
2018-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRSTransducer, Blood-Pressure, Extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152980000Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC2016-01-19DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103197773PackageGS11In Commercial Distribution
00690103197778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010319777350690103197773
00690103197778006901031977786901031977780690103197778

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length84Inch

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103020212CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M242015-09-24
00690103020229CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M262015-09-24
00690103020236CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M282015-09-24
00690103020243CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M302015-09-24
00690103020250CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M322015-09-24
00690103020267CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M342015-09-24
00690103020274CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M362015-09-24
00690103020281CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M382015-09-24
00690103020298CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M402015-09-24
00690103219807SAPIEN Stabilizer Rail System9880SRS9880SRSA2026-10-22
00690103222135PASCAL Precision20000ISM20000ISMTA2026-10-22
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103216943PASCAL20000IS20000ISA2022-09-19
00690103216967PASCAL PRECISION20000GSA20000GSA2022-09-19
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16

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Primary DI, Brand, Company table
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