FDA.reportPublic FDA data

SLX Hemo-Cath®

Primary DI
50884908175221
Brand
SLX Hemo-Cath®
Company
Medical Components, Inc.
Model
MC061422MB
Catalog number
MC061422MB
Device description
14F X 15CM SLX MAX BARRIER TRAY
Published
2024-08-28
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
LFJCatheter, subclavian

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFJCatheter, SubclavianGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908175221PackageGS14In Commercial Distribution
00884908175226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490817522150884908175221
00884908175226008849081752268849081752260884908175226

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular 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, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.

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
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
00884908092769T-3 TRIPLE LUMEN CTMC0135032016-02-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902197129ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
10801902197136ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
00884908183894HEMO-CATH® SILICONEMedical Components, Inc.LFJ2026-03-28
00884908183900HEMO-CATH® SILICONEMedical Components, Inc.LFJ2026-03-28
00884908183917SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908183948SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908187625SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908187632SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
50884908183912SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908183943SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187620SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187637SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
10801902223033ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223040ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223057ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223036ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223043ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223050ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902212211ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
20801902212218ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
10801902190373ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
20801902190370ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
00884908175226SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175233SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175240SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175257SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28
50884908175238SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175245SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175252SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28
00884908175431Hemo-Cath®Medical Components, Inc.LFJ2024-05-11