FDA.report

ARROW

Primary DI
40801902111829
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036192
Catalog number
CDC-15123-XP1A
Device description
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Published
2017-05-03
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

Related Records

Contact Domains

Product Codes

CodeName
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Product Code Classifications

CodeDeviceSpecialtyClass
NIECatheter, Hemodialysis, Triple Lumen, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40801902111829PackageGS15In Commercial Distribution
30801902111822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4080190211182940801902111829
3080190211182230801902111822

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store between 20 - 25C (68 - 77F).
Special Storage Condition, Specify00Store between 20 - 25°C (68 - 77°F).
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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 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