FDA.reportPublic FDA data

ARROW

Primary DI
30801902111693
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036179
Catalog number
AK-12123-PCDC
Device description
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Sharps Safety Features
Published
2018-12-11
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
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIECatheter, Hemodialysis, Triple Lumen, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902111693PackageGS15Not in Commercial Distribution
40801902111690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3080190211169330801902111693
4080190211169040801902111690

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis/central venous catheterization kitA collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enabling central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes a nonimplantable triple-lumen haemodialysis catheter, devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20801902222453ARROWTELEFLEX INCORPORATEDNIE2025-04-03
20801902222460ARROWTELEFLEX INCORPORATEDNIE2025-04-03
50884908182649TRIO-CT®Medical Components, Inc.NIE2025-03-18
50884908182656TRIO-CT®Medical Components, Inc.NIE2025-03-18
50884908182663TRIO-CT®Medical Components, Inc.NIE2025-03-18
50884908182670TRIO-CT®Medical Components, Inc.NIE2025-03-18
50884908182687TRIO-CT®Medical Components, Inc.NIE2025-03-18
5088490818284712F TRI-FLOW TRIPLE LUMEN CATHETERMedical Components, Inc.NIE2025-03-18
5088490818285412F TRI-FLOW TRIPLE LUMEN CATHETERMedical Components, Inc.NIE2025-03-18
5088490818286112F TRI-FLOW TRIPLE LUMEN CATHETERMedical Components, Inc.NIE2025-03-18
5088490818287812F TRI-FLOW TRIPLE LUMEN CATHETERMedical Components, Inc.NIE2025-03-18
5088490818288512F TRI-FLOW TRIPLE LUMEN CATHETERMedical Components, Inc.NIE2025-03-18
50884908182595TRIO-CT®Medical Components, Inc.NIE2025-03-05
50884908182601TRIO-CT®Medical Components, Inc.NIE2025-03-05
50884908182618TRIO-CT®Medical Components, Inc.NIE2025-03-05
50884908182625TRIO-CT®Medical Components, Inc.NIE2025-03-05
50884908182632TRIO-CT®Medical Components, Inc.NIE2025-03-05
20801902202431ARROWTELEFLEX INCORPORATEDNIE2024-09-06
20801902202448ARROWTELEFLEX INCORPORATEDNIE2024-09-06
50884908178680TRIO-CT®Medical Components, Inc.NIE2024-02-29
50884908178697TRIO-CT®Medical Components, Inc.NIE2024-02-29
50884908178703TRIO-CT®Medical Components, Inc.NIE2024-02-29
50884908178710TRIO-CT®Medical Components, Inc.NIE2024-02-29
50884908133245TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133252TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133269TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133276TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133344TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133351TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133368TRIO-CTMedical Components, Inc.NIE2023-12-30