FDA.reportPublic FDA data

T-3 Triple Lumen CT

Primary DI
50884908092801
Brand
T-3 Triple Lumen CT
Company
Medical Components, Inc.
Model
MC013542
Device description
15.5F X 20CM T-3 TRIPLE LUMEN CT (CATHETER ONLY)
Published
2015-10-23
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
50884908092801PackageGS15In Commercial Distribution
00884908092806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490809280150884908092801
00884908092806008849080928068849080928060884908092806

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags#

DUNS number
038000253
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
50884908183912SLX Hemo-Cath®MC061405MC0614052026-03-21
50884908183943SLX Hemo-Cath®MC061404MC0614042026-03-21
50884908187620SLX Hemo-Cath®MC061424MBMC061424MB2026-03-21
50884908187637SLX HEMO-CATH®MC061425MBMC061425MB2026-03-21
30884908188456MICRO-STICK SETDMRAH190411DMRAH1904112026-02-19
30884908188463MICRO-STICK SETDMRAH190421DMRAH1904212026-02-19
50884908188474MICRO-STICK SETDMRAH190511DMRAH1905112026-02-19
50884908188481MICRO-STICK SETDMRAH190521DMRAH1905212026-02-19
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28036301MD280363012026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037201MD280372012026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037101MD280371012026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)MR28036304MR280363042026-02-17
50884908152703PRO-PICC® CTMD17035201MD170352012026-02-17
50884908154714PRO-PICC® CTMD17036201MD170362012026-02-17
50884908154721PRO-PICC® CTMD17036301MD170363012026-02-17
50884908160234PRO-PICC® CTMD17035101MD170351012026-02-17
50884908160258PRO-PICC® CTMD17034101MD170341012026-02-17
50884908174361PRO-PICC® CTMD17035105MD170351052026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMD17013101MD170131012026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMD17013105MD170131052026-02-13

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
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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
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50884908133344TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133351TRIO-CTMedical Components, Inc.NIE2023-12-30
50884908133368TRIO-CTMedical Components, Inc.NIE2023-12-30