FDA.reportPublic FDA data

ARROW

Primary DI
20801902197423
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN920746
Catalog number
CAR-05500
Device description
Cannon(R) II Plus Catheter Replacement Hub
Published
2022-11-09
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
10801902197426PackageGS11In Commercial Distribution
30801902197420PackageGS11In Commercial Distribution
20801902197423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080190219742610801902197426
3080190219742030801902197420
2080190219742320801902197423

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.

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
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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
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
00884908001891Catheter Repair KitMedical Components, Inc.NFK2015-10-23