FDA.reportPublic FDA data

ARROW

Primary DI
10801902213416
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN927333
Catalog number
CDC-12123-XPCN1A
Device description
Pressure Injectable Three-Lumen Hemodialysis Catheterization for High Volume Infusions
Published
2023-04-20
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
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
20801902213413PackageGS15In Commercial Distribution
10801902213416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221341320801902213413
1080190221341610801902213416

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.

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
Combination product
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
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884908166330T-3 Triple Lumen CTMedical Components, Inc.NIE2026-07-24
00801741238062PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238079PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238086PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238093PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238109PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238116PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238130PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238147PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238253Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238260Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238277Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238284Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238291Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238307Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238314Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238321Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238413PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238420PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238437PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238444PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238451PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238468PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238475PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238482PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
10801902222456ARROWTELEFLEX INCORPORATEDNIE2025-04-03
10801902222463ARROWTELEFLEX INCORPORATEDNIE2025-04-03
10801902202434ARROWTELEFLEX INCORPORATEDNIE2024-09-06
10801902202441ARROWTELEFLEX INCORPORATEDNIE2024-09-06
10801902213409ARROWTELEFLEX INCORPORATEDNIE2023-04-20