FDA.reportPublic FDA data

Pro-Line® CT

Primary DI
00884908034608
Brand
Pro-Line® CT
Company
Medical Components, Inc.
Model
MR28035101
Device description
5F X 60CM SINGLE LUMEN Pro-Line® CT BASIC IR SET
Published
2015-10-22
Public version status
Update
Distribution status
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
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908034603PackageGS15Not in Commercial Distribution
00884908034608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490803460350884908034603
00884908034608008849080346088849080346080884908034608

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
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H787MRC3S950C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S970C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H965458160BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H965458560BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H96560M13031150BioFloNAVILYST MEDICAL, INC.LJS2021-06-24
H96560M13031130BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
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H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14