FDA.report

ARROW

Primary DI
10801902053371
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN035675
Catalog number
CS-15272-XM
Device description
NextStep(R) Retograde Hemodialysis Catheterization Set with Arrow(R) Simplicity(TM) Long-Term Access, Cuff to Tip: 27 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

Related Records

Contact Domains

Product Codes

CodeName
MSDCatheter, hemodialysis, implanted

Product Code Classifications

CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801902053371PackageGS11Not in Commercial Distribution
30801902053375PackageGS11Not in Commercial Distribution
00801902053374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080190205337110801902053371
3080190205337530801902053375
00801902053374008019020533748019020533740801902053374

GMDN Terms

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

TypeValueUnit
Catheter Gauge15French
Length27Centimeter

Sterilization Methods

Method

Contacts

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

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30841156103983SUPERCROSS530253022026-03-23
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20841156104013SUPERCROSS530553052026-03-23
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20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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10884450820794CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-11
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