FDA.reportPublic FDA data

PressureWire™

Primary DI
15414734055755
Brand
PressureWire™
Company
ST. JUDE MEDICAL, INC.
Model
Certus™ Agile Tip
Catalog number
C12008
Published
2015-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTRANSDUCER, PRESSURE, CATHETER TIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734055755PackageGS15In Commercial Distribution
05414734055758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473405575515414734055755
05414734055758054147340557585414734055758

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length175Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067057341Navitor™NVRO-35NVRO-352026-11-05
05415067057365Navitor™NVRO-29NVRO-292026-11-05
05415067057389Navitor™NVRO-27NVRO-272026-11-05
05415067057402Navitor™NVRO-25NVRO-252026-11-05
05415067057426Navitor™NVRO-23NVRO-232026-11-05
05415067057242Amplatzer™9-APVL-1439-APVL-1432026-11-02
05415067057259Amplatzer™9-APVL-0849-APVL-0842026-11-02
05415067057266Amplatzer™9-APVL-1239-APVL-1232026-11-02
05415067057273Amplatzer™9-APVL-0639-APVL-0632026-11-02
05415067057280Amplatzer™9-APVL-1059-APVL-1052026-11-02
05415067057297Amplatzer™9-APVL-0429-APVL-0422026-11-02
05415067057303Amplatzer™9-APVL-1039-APVL-1032026-11-02
05415067057310Amplatzer™9-APVL-1259-APVL-1252026-11-02
05415067057327Amplatzer™9-APVL-1459-APVL-1452026-11-02
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540184010127OptoMonitorOpsens IncDXO2026-09-30
07540184020027OptoMonitorOpsens IncDXO2026-09-30
07540184020034OptoMOnitorOpsens IncDXO2026-09-30
07540184020041OptoMonitorOpsens IncDXO2026-09-30
07540184020058OptoMonitorOpsens IncDXO2026-09-30
07540184020065OptoMonitorOpsens IncDXO2026-09-30
07540184020072OptoMonitorOpsens IncDXO2026-09-30
00885403533665TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543282TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543299TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543305TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543312TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543428TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543435TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543466TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543473TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543480TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544128TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544135TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544142TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544159TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544166TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544180TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544432TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544470TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544487TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544494TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544500TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544524TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18