FDA.reportPublic FDA data

ARROW

Primary DI
20801902211334
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN925158
Catalog number
ASK-04001-UCHD
Device description
Arrow(R) VPS(R) Access Kit for use with 5 Fr. PICC
Published
2022-06-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103255000VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETVasonova, Inc.2011-02-18OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902211334PackageGS13In Commercial Distribution
10801902211337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221133420801902211334
1080190221133710801902211337

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
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