FDA.reportPublic FDA data

ARROW

Primary DI
00801902081490
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN035983
Catalog number
VPS-G4SC
Device description
Sterile Covers for use with VPS-G4C
Published
2016-09-16
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
KKKSUDAN IV

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKKSudan IvHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050322000MICROTEK EQUIPMENT DRAPESMicrotek Medical, Inc.2005-05-17KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902081491PackageGS140In Commercial Distribution
00801902081490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190208149130801902081491
00801902081490008019020814908019020814900801902081490

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.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336101012Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108813Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108998Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336114630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108810Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336114637Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00840216101784ASP Medical Asp Global, LLCKKK2022-08-02
10840216101781ASP Medical Asp Global, LLCKKK2022-08-02
10634916809401Side DrapeSTANDARD TEXTILE CO., INC.KKK2021-06-11
10888277563889MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
40888277563880MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
10080196895410MedlineMEDLINE INDUSTRIES, INC.KKK2021-01-26
10080196747924MedlineMEDLINE INDUSTRIES, INC.KKK2020-12-17
00851354004264Sterile DrapeAVINGER, INC.KKK2019-03-21
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2017-03-02
10080196308200MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196722938MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196915033MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
40080196308201MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
30801902081491ARROWTELEFLEX INCORPORATEDKKK2016-09-16
20845225012681SpinVision STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2016-09-08
10845225012707R-100 STERILE EQUIPMENT COVERPhilips Image Guided Therapy CorporationKKK2016-09-08
10885380064234CONVERTORSCardinal Health 200, LLCKKK2016-06-28
50885380064232CONVERTORSCardinal Health 200, LLCKKK2016-06-28