FDA.reportPublic FDA data

T-3 TRIPLE LUMEN CT

Primary DI
00884908092769
Brand
T-3 TRIPLE LUMEN CT
Company
Medical Components, Inc.
Model
MC013503
Device description
15.5F X 24CM T-3 TRIPLE LUMEN CT CATHETER BASIC SET
Published
2016-02-23
Public version status
Update
Distribution status
Not 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
50884908092764PackageGS15Not in Commercial Distribution
00884908092769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490809276450884908092764
00884908092769008849080927698849080927690884908092769

GMDN Terms#

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

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
00884908189674MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641501DMC6415012026-08-08
00884908189681MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641502DMC6415022026-08-08
00884908189698MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641503DMC6415032026-08-08
00884908189704MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641504DMC6415042026-08-08
00884908189711MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641505DMC6415052026-08-08
00884908189728MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641506DMC6415062026-08-08
00884908166330T-3 Triple Lumen CTMC013505MC0135052026-07-24
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDTHD155165DTHD1551652025-11-27
00884908092752T-3 Triple Lumen CTMC0135022015-10-23
00884908016901GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREG130NG130N2018-10-06
00884908105254GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900202017-11-28
00884908105278GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900402017-12-02
00884908145090GALT GUIDEWIREGALT GUIDEWIREDMR190040DMR1900402019-09-04
00884908136630DUO-FLOW® SIDE X SIDEAS0914151AS09141512026-05-13
00884908136647DUO-FLOW® SIDE X SIDEAS0914201AS09142012026-05-13
00884908136654DUO-FLOW® SIDE X SIDEAS0914241AS09142412026-05-13
00884908136661DUO-FLOW® SIDE X SIDEAC0914151AC09141512026-05-13
00884908136678DUO-FLOW® SIDE X SIDEAC0914201AC09142012026-05-13
00884908136685DUO-FLOW® SIDE X SIDEAC0914241AC09142412026-05-13
00884908140798BREEZE® SECUREMENTBL0512BL05122022-02-26

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
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10801902202434ARROWTELEFLEX INCORPORATEDNIE2024-09-06
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10801902213409ARROWTELEFLEX INCORPORATEDNIE2023-04-20