FDA.reportPublic FDA data

OmniWire Pressure guide wire

Primary DI
00845225003043
Brand
OmniWire Pressure guide wire
Company
Philips Image Guided Therapy Corporation
Model
89185
Catalog number
89185
Published
2020-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192886000
K202543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192886000OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation2020-03-26DQX
K202543000OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation2020-09-28DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225003043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225003043008452250030438452250030430845225003043

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
Length185Centimeter
Outer Diameter0.014Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
018860556
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132029326Quick-Cross Support Catheter518-032518-0322022-02-22
00813132029333Quick-Cross Support Catheter518-033518-0332022-02-22
00813132029340Quick-Cross Support Catheter518-034518-0342022-02-22
00813132029357Quick-Cross Support Catheter518-035518-0352022-02-22
00813132029364Quick-Cross Support Catheter518-036518-0362022-02-22
00813132029371Quick-Cross Support Catheter518-037518-0372022-02-22
00813132029388Quick-Cross Support Catheter518-038518-0382022-02-22
00813132029395Quick-Cross Support Catheter518-065518-0652022-02-22
00813132029401Quick-Cross Support Catheter518-066518-0662022-02-22
00813132029418Quick-Cross Extreme Support Catheter518-084518-0842023-10-04
00813132029425Quick-Cross Extreme Support Catheter518-086518-0862023-10-04
00813132029432Quick-Cross Extreme Support Catheter518-088518-0882023-10-04
00813132029449Quick-Cross Extreme Support Catheter518-090518-0902023-10-04
00813132029456Quick-Cross Extreme Support Catheter518-092518-0922023-10-04
00813132029470Quick-Cross Extreme Support Catheter518-078518-0782023-10-04
00813132029487Quick-Cross Extreme Support Catheter518-080518-0802023-10-04
00813132029494Quick-Cross Extreme Support Catheter518-082518-0822023-10-04
00813132029517Quick-Cross Select Support Catheter518-085518-0852023-10-04
00813132029524Quick-Cross Select Support Catheter518-087518-0872023-10-04
00813132029531Quick-Cross Select Support Catheter518-089518-0892023-10-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403526322TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526599TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
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00885403539889TruWaveBecton, Dickinson And CompanyDXO2026-09-05
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00885403542742TRUWAVE, VAMP JRBecton, Dickinson And CompanyDXO2026-09-05
00885403542803TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542810TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403524861TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-04