FDA.reportPublic FDA data

ARROW

Primary DI
00801902029249
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN030872
Catalog number
CV-13122-F
Device description
You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue Flextip(R) Catheter for High Volume Infusions
Published
2015-10-16
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
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
30801902029240PackageGS15In Commercial Distribution
00801902029249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190202924030801902029240
00801902029249008019020292498019020292490801902029249

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
Length13Centimeter

Storage And Handling#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00884908175431Hemo-Cath®Medical Components, Inc.LFJ2024-05-11
00884908175448Hemo-Cath®Medical Components, Inc.LFJ2024-05-11