FDA.reportPublic FDA data

ARROW

Primary DI
20801902211563
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN926119
Catalog number
VPS-G4SC
Device description
Sterile Covers for use with VPS-G4C
Published
2022-08-05
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902211563PackageGS140In Commercial Distribution
10801902211566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221156320801902211563
1080190221156610801902211566

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, single-useA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
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
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
57613327664091Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664107Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
04056869281483AcuNav Crystal Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-01-03
40841716103511ACIST HDi® HD IVUS SystemACIST MEDICAL SYSTEMS, INC.OBJ2024-11-13
04056869997445AcuNav Lumos 4D ICE catheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2024-07-19
10846835022780SOUNDSTAR CRYSTAL Ultrasound CatheterBiosense Webster IncOBJ2024-06-26
00850045446000SLT IVUS P1 Pulser Receiver UnitProvisio Medical, Inc.OBJ2024-05-24
00850045446031SLT IVUS P1 Display UnitProvisio Medical, Inc.OBJ2024-05-24
00850045446048SLT IVUS P1 CartProvisio Medical, Inc.OBJ2024-05-24
20801902219002ARROWTELEFLEX INCORPORATEDOBJ2024-03-08
20801902219064ARROWTELEFLEX INCORPORATEDOBJ2024-03-08
00191506035433OptiCross™ 6BOSTON SCIENTIFIC CORPORATIONOBJ2023-09-21
087193277373094 Fr PV CatheterCD LeycomOBJ2023-09-20
087193277373164 Fr PV CatheterCD LeycomOBJ2023-09-20
087193277373237 Fr PV-CatheterCD LeycomOBJ2023-09-20
087193277373307 Fr PV-CatheterCD LeycomOBJ2023-09-20
087193277373477 Fr PV-CatheterCD LeycomOBJ2023-09-20
B227NRP0140NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2023-07-12
10846835025194NUVISION NAV Ultrasound CatheterBiosense Webster IncOBJ2023-07-03
00628055603115Novasight Hybrid™ CatheterConavi Medical IncOBJ2023-04-17
00628055603092Novasight Hybrid™ PIMConavi Medical IncOBJ2022-10-25
00195278505330VividGE Vingmed Ultrasound ASOBJ2022-09-20