FDA.reportPublic FDA data

ARROW

Primary DI
10801902053395
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN035686
Catalog number
CS-15312-XM
Device description
NextStep(R) Retograde Hemodialysis Catheterization Set with Arrow(R) Simplicity(TM) Long-Term Access, Cuff to Tip: 31 cm
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801902053395PackageGS11Not in Commercial Distribution
30801902053399PackageGS11Not in Commercial Distribution
00801902053398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080190205339510801902053395
3080190205339930801902053399
00801902053398008019020533988019020533980801902053398

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableA sterile, 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. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French
Length31Centimeter

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
true
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
00884450458426DuraMax®Merit Medical Systems, Inc.MSD2026-03-24
00884450458303DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458310DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458327DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458358DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
10884450458409DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458433DuraMaxMerit Medical Systems, Inc.MSD2026-03-20
10884450458218DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458362DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458386DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458416DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458232DuraMax®Merit Medical Systems, Inc.MSD2026-03-11
10884450793913BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-02-28
10884450795078DuraFlow™2Merit Medical Systems, Inc.MSD2026-02-26
10884450826888ProGuide™Merit Medical Systems, Inc.MSD2026-01-13
10884450793791BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-01-03
10884450794804DuraMax®Merit Medical Systems, Inc.MSD2026-01-03
10884450795115DuraFlow™2Merit Medical Systems, Inc.MSD2026-01-03
50884908185145MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
50884908185152MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
20884521811116RitusMozarc Medical US LLCMSD2025-11-27
10884450794828DuraMax®Merit Medical Systems, Inc.MSD2025-09-13
10884450795030DuraFlow™2Merit Medical Systems, Inc.MSD2025-09-06
10884450793777BioFlo DuraMax®Merit Medical Systems, Inc.MSD2025-09-04
10884450795122DuraFlow™2Merit Medical Systems, Inc.MSD2025-07-26
10884450793227BioFlo DuraMax®Merit Medical Systems, Inc.MSD2025-07-23
10884450820787CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-23
10884450827236ProGuide™Merit Medical Systems, Inc.MSD2025-07-16
10884450820794CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-11
50884908130503Hemo-Flow®Medical Components, Inc.MSD2025-06-26