FDA.reportPublic FDA data

PressureWire™

Primary DI
05414734055819
Brand
PressureWire™
Company
ST. JUDE MEDICAL, INC.
Model
C12358
Catalog number
C12358
Device description
Guidewire Mounted Sensor
Published
2015-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWIRE, GUIDE, CATHETER
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
DXOTRANSDUCER, PRESSURE, CATHETER TIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140466000PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300St. Jude Medical Systems AB2014-11-13DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734055816PackageGS15In Commercial Distribution
05414734055819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473405581615414734055816
05414734055819054147340558195414734055819

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-tip transducer, pressureA device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Centimeter

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
Lot or batch
true
Expiration date on label
true

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00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
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