FDA.reportPublic FDA data

ARROW

Primary DI
20801902096245
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN030092
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFJCATHETER, SUBCLAVIAN
NIECatheter, hemodialysis, triple lumen, non-implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFJCatheter, SubclavianGastroenterology, Urology2
NIECatheter, Hemodialysis, Triple Lumen, Non-ImplantedGastroenterology, 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
20801902096245PackageGS15In Commercial Distribution
10801902096248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190209624520801902096245
1080190209624810801902096248

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA sterile, 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

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902197129ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
10801902197136ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
00884908166330T-3 Triple Lumen CTMedical Components, Inc.NIE2026-07-24
10801902223033ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223040ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223057ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902212211ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
10801902222456ARROWTELEFLEX INCORPORATEDNIE2025-04-03
10801902222463ARROWTELEFLEX INCORPORATEDNIE2025-04-03
10801902190373ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
10801902202434ARROWTELEFLEX INCORPORATEDNIE2024-09-06
10801902202441ARROWTELEFLEX INCORPORATEDNIE2024-09-06
10801902212228ARROWTELEFLEX INCORPORATEDLFJ2023-06-27
10801902215205ARROWTELEFLEX INCORPORATEDLFJ2023-06-05
10801902215243ARROWTELEFLEX INCORPORATEDLFJ2023-06-05
10801902213409ARROWTELEFLEX INCORPORATEDNIE2023-04-20
10801902213416ARROWTELEFLEX INCORPORATEDNIE2023-04-20
10801902213423ARROWTELEFLEX INCORPORATEDNIE2023-04-20
10801902213447ARROWTELEFLEX INCORPORATEDNIE2023-04-19
10801902213454ARROWTELEFLEX INCORPORATEDNIE2023-04-19
10801902190168ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
10801902190212ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
10801902190229ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
10801902190236ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
10801902190366ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
10801902190502ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
10801902186499ARROWTELEFLEX INCORPORATEDNIE2022-01-05
10801902186338ARROWTELEFLEX INCORPORATEDNIE2021-12-29
10801902186369ARROWTELEFLEX INCORPORATEDNIE2021-12-29
10884521794733MAHURKARMozarc Medical US LLCLFJ2020-04-12