FDA.reportPublic FDA data

ARROW

Primary DI
10801902212211
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN926656
Catalog number
CV-12122-FBZ
Device description
Two-Lumen Hemodialysis Catheter for High Volume Infusions
Published
2025-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20801902212218PackageGS15In Commercial Distribution
10801902212211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221221820801902212218
1080190221221110801902212211

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149471QUIKCLOT1881882026-07-17
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
14026704930644QUIKCLOT1831832026-07-17
14026704930651QUIKCLOT1831832026-07-17
14026704930668QUIKCLOT1881882026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930682QUIKCLOT3743742026-07-17
14026704930699QUIKCLOT3743742026-07-17
14026704930705QUIKCLOT4584582026-07-17
14026704930729QUIKCLOT4594592026-07-17

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
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
00884908175455Hemo-Cath®Medical Components, Inc.LFJ2024-05-11