FDA.reportPublic FDA data

ARROW

Primary DI
10801902195538
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN920515
Catalog number
CS-15282-I
Device description
Arrow Edge(R) Hemodialysis Catheter
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111117000CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...Teleflexmedical, Inc.2011-06-30MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801902195538PackageGS11In Commercial Distribution
20801902195535PackageGS11In Commercial Distribution
30801902195532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080190219553810801902195538
2080190219553520801902195535
3080190219553230801902195532

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21
14026704930767QUIKCLOT4614612026-07-17
00801902102782ARROWIPN030321SAC-008222016-09-16
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149488QUIKCLOT1881882026-07-17
10841495149495QUIKCLOT3743742026-07-17
10841495149501QUIKCLOT3743742026-07-17
10841495149518QUIKCLOT4584582026-07-17
10841495149549QUIKCLOT4594592026-07-17
10841495149563QUIKCLOT4604602026-07-17
10841495149587QUIKCLOT4614612026-07-17
10841495149600QUIKCLOT467Z467Z2026-07-17
10841495149624QUIKCLOT4874872026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30801902193538ARROWTELEFLEX INCORPORATEDMSD2026-07-22
00884450468913DuraMax®Merit Medical Systems, Inc.MSD2026-07-08
00884450820759CentrosFLO®Merit Medical Systems, Inc.MSD2026-06-25
00884450467572DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469033BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469132BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
10801902096606ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801902096620ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801902096668ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801741074490ClampsBard Access Systems, Inc.MSD2016-09-16
10801902126693ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126709ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126716ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126723ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126730ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126747ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126754ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126761ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126778ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126785ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126792ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126808ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127157ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127164ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127171ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127188ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127195ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127201ARROWTELEFLEX INCORPORATEDMSD2016-09-16