FDA.reportPublic FDA data

ViewFlex™

Primary DI
05415067002082
Brand
ViewFlex™
Company
IRVINE BIOMEDICAL, INC.
Model
D087031
Catalog number
D087031
Device description
Xtra ICE Catheter
Published
2016-01-12
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
OBJCatheter, ultrasound, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133853000
K223077000
K251231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133853000VIEWFLEX XTRA ICE CATHETERIrvine Biomedical, Inc., A St. Jude Medical Company2014-05-19OBJ
K223077000ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company2022-12-07OBJ
K251231000ViewFlex™ X ICE Catheter, Sensor Enabled™ABBOTT MEDICAL2025-05-20OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067002082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067002082054150670020825415067002082

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac ultrasound imaging catheter, steerable, single-useA steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Keep dry, keep away from sunlight, and protect from heat and radioactive sources.. Excursions permitted: -20C – 50C and Humidity 15% - 90%
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
926346966
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
false
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
05414734303415Inquiry™IBI-81199IBI-811992016-03-18
05414734303538Inquiry™IBI-81213IBI-812132015-02-10
05414734303613Inquiry™IBI-81221IBI-812212015-02-10
05414734309257NAIBI-85942IBI-859422025-12-09
05415067053190ViewFlex™ICE-VF-SE-2D-01ICE-VF-SE-2D-012025-11-21
05415067016669Cool Point™H701666H7016662024-01-12
05414734308830NAIBI-85710IBI-857102014-10-31
05414734309080NAIBI-85786IBI-857862014-10-31
05415067008985Cool Point™IBI-89003IBI-890032014-09-29
05414734258616Cool Point™85785857852014-09-29
05414734302975Inquiry™IBI-81104IBI-811042015-02-10
05414734303132Inquiry™IBI-81120IBI-811202015-03-10
05414734303149Inquiry™IBI-81121IBI-811212015-03-10
05414734303163Inquiry™IBI-81124IBI-811242015-03-10
05414734303170Inquiry™IBI-81125IBI-811252015-05-22
05414734303187Inquiry™IBI-81126IBI-811262015-05-22
05414734303217Inquiry™IBI-81130IBI-811302015-03-10
05414734303248Inquiry™IBI-81134IBI-811342015-03-10
05414734303309Inquiry™IBI-81144IBI-811442015-03-10
05414734303477Inquiry™IBI-81207IBI-812072015-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-09-18
00845225013011ICE PIMPhilips Image Guided Therapy CorporationOBJ2026-07-30
10801902219333ARROWTELEFLEX INCORPORATEDOBJ2026-07-30
10801902194654ARROWTELEFLEX INCORPORATEDOBJ2026-07-29
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
00884838112988Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
04056869957708AcuNav CRYSTAL G Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-11-21
05415067053190ViewFlex™IRVINE BIOMEDICAL, INC.OBJ2025-11-21
00845225003319Visions PV .014P RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003364Eagle Eye Platinum RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003371Eagle Eye Platinum ST RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
10841716103602ACIST Kodama® Coronary Imaging CatheterACIST MEDICAL SYSTEMS, INC.OBJ2025-08-14
10846835026559NUVISION NAV Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
10846835026566NUVISION Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
00884838126893EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126909Affiniti CVx Diagnostic Ultrasound System Philips Ultrasound LLCOBJ2025-06-23
00884838126923EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126930EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126947Affiniti CVx Diagnostic Ultrasound System Circular EditionPhilips Ultrasound LLCOBJ2025-06-23
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-19
00845225012854ICE PIMPhilips Image Guided Therapy CorporationOBJ2025-03-24
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11