FDA.reportPublic FDA data

TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERS

Primary DI
00884908097009
Brand
TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERS
Company
Medical Components, Inc.
Model
MC3L-8S-PA
Device description
7F X 20CM TRIPLE LUMEN7F X 20CM INFUSION CATHETER TRAYINFUSION C
Published
2017-03-16
Public version status
Update
Distribution status
Not 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
JCYCATHETER, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCYCatheter, InfusionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908097004PackageGS110Not in Commercial Distribution
00884908097009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490809700450884908097004
00884908097009008849080970098849080970090884908097009

GMDN Terms#

Term, Definition table
TermDefinition
Centrally-inserted central venous catheterA flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884908140804BREEZE® SECUREMENTBL1218BL12182022-02-26
00884908186697DIGNITY®MRDP80ALNMRDP80ALN2026-04-23
00884908186703DIGNITY®MRDP80ALSMRDP80ALS2026-04-23
00884908186710DIGNITY®MRDP80AMNMRDP80AMN2026-04-23
00884908186727DIGNITY®MRDP80AMSMRDP80AMS2026-04-23
00884908186734DIGNITY®MRDP80ASNMRDP80ASN2026-04-23
00884908186741DIGNITY®MRDP80AXSMRDP80AXS2026-04-23
00884908186758DIGNITY®MRDP80PLNMRDP80PLN2026-04-23
00884908186765DIGNITY®MRDP80PMNMRDP80PMN2026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10680651385250HalyardO&M HALYARD, INC.JCY2023-07-31
30680651385254HalyardO&M HALYARD, INC.JCY2023-07-31
00884908175646TRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2023-06-17
50884908175641TRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2023-06-17
06974567743462EMSRUNWuxi Emsrun Technology Co., Ltd.JCY2022-12-06
00884908147056N/AN/AMedical Components, Inc.JCY2019-10-02
00884908147063N/AN/AMedical Components, Inc.JCY2019-10-02
00884908147070N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147051N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147068N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147075N/AN/AMedical Components, Inc.JCY2019-10-02
00884908146394INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146400INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146417INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146424INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146431INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146399INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146405INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146412INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146429INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146436INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908029048N/AN/AMedical Components, Inc.JCY2019-07-02
50884908029043N/AN/AMedical Components, Inc.JCY2019-07-02
50884908097004TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
04046964189555Blood Spike AdapterB. BRAUN MEDICAL INC.JCY2016-09-23