FDA.reportPublic FDA data

ARROW

Primary DI
10801902001136
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN030091
Catalog number
CS-15122-F
Device description
Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions
Published
2018-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFJCATHETER, SUBCLAVIAN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFJCatheter, SubclavianGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895417000ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITArrow Intl., Inc.1990-01-03LFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902001133PackageGS15Not in Commercial Distribution
10801902001136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190200113320801902001133
1080190200113610801902001136

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein 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 and may be radiopaque; 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 Gauge12French
Length20Centimeter

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
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31
05060112310621LMA AIRWAY MANAGEMENTIPN9018661500252026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902197129ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
10801902197136ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
00884908183894HEMO-CATH® SILICONEMedical Components, Inc.LFJ2026-03-28
00884908183900HEMO-CATH® SILICONEMedical Components, Inc.LFJ2026-03-28
00884908183917SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908183948SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908187625SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908187632SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
50884908183912SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908183943SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187620SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187637SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
10801902223033ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223040ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223057ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223036ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223043ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223050ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902212211ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
20801902212218ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
10801902190373ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
20801902190370ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
00884908175226SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175233SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175240SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175257SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28
50884908175221SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175238SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175245SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175252SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28