FDA.reportPublic FDA data

ARROW

Primary DI
00801902096814
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN033234
Catalog number
NRH-15272
Device description
NextStep Catheter(R) Retrograde Replacement Hub Set Fits 15 Fr. x 27 cm Models
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFKKit, repair, catheter, hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFKKit, Repair, Catheter, HemodialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020430000DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)Diatek, Inc.2002-05-09NFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801902096811PackageGS11Not in Commercial Distribution
30801902096815PackageGS11Not in Commercial Distribution
00801902096814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080190209681110801902096811
3080190209681530801902096815
00801902096814008019020968148019020968140801902096814

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French
Length27Centimeter

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
No natural rubber latex
true

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
20801902197379ARROWTELEFLEX INCORPORATEDNFK2022-12-08
10801902197372ARROWTELEFLEX INCORPORATEDNFK2022-12-08
20801902197355ARROWTELEFLEX INCORPORATEDNFK2022-12-02
30801902197352ARROWTELEFLEX INCORPORATEDNFK2022-12-02
20801902197409ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902197461ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902197485ARROWTELEFLEX INCORPORATEDNFK2022-12-01
10801902197402ARROWTELEFLEX INCORPORATEDNFK2022-12-01
30801902197468ARROWTELEFLEX INCORPORATEDNFK2022-12-01
10801902197488ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902195337ARROWTELEFLEX INCORPORATEDNFK2022-11-15
20801902196723ARROWTELEFLEX INCORPORATEDNFK2022-11-15
30801902195334ARROWTELEFLEX INCORPORATEDNFK2022-11-15
30801902196720ARROWTELEFLEX INCORPORATEDNFK2022-11-15
20801902195238ARROWTELEFLEX INCORPORATEDNFK2022-11-11
30801902195235ARROWTELEFLEX INCORPORATEDNFK2022-11-11
20801902197423ARROWTELEFLEX INCORPORATEDNFK2022-11-09
10801902197426ARROWTELEFLEX INCORPORATEDNFK2022-11-09
00884908158205CATHETER REPAIR KITMedical Components, Inc.NFK2020-11-26
30884908158206CATHETER REPAIR KITMedical Components, Inc.NFK2020-11-26
00884908146042N/AMedical Components, Inc.NFK2019-09-05
30884908146043N/AMedical Components, Inc.NFK2019-09-05
00801741045080Catheter Repair KitBard Access Systems, Inc.NFK2017-05-29
10801741045087Catheter Repair KitBard Access Systems, Inc.NFK2017-05-29
00801741045103Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
00801741045110RetrO Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
20801741045107Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
20801741045114RetrO Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
00884908039658CATHETER REPAIR KITMedical Components, Inc.NFK2015-10-24
00884908039856REPAIR KITMedical Components, Inc.NFK2015-10-23