FDA.reportPublic FDA data

N/AN/A

Primary DI
50884908029043
Brand
N/AN/A
Company
Medical Components, Inc.
Model
MC3L-8K
Catalog number
MC3L-8K
Device description
7F X 20CM TRIPLE LUMEN7F X 20CM INFUSION CATHETER KITINFUSION CA
Published
2019-07-02
Public version status
New
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
JCYCATHETER, INFUSION

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908029043PackageGS110In Commercial Distribution
00884908029048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490802904350884908029043
00884908029048008849080290488849080290480884908029048

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterA sterile, 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.

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
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 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
00884908097009TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
50884908097004TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
04046964189555Blood Spike AdapterB. BRAUN MEDICAL INC.JCY2016-09-23