FDA.reportPublic FDA data

SPLIT CATH®III

Primary DI
50884908142575
Brand
SPLIT CATH®III
Company
Medical Components, Inc.
Model
DASPC2816-3
Catalog number
DASPC2816-3
Device description
16F X 28CM SPLIT CATH®III CATHETER SETCATHETER SET (CUFF 23CM FROM TIP)(CUFF 23CM F
Published
2019-06-15
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
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908142575PackageGS15In Commercial Distribution
00884908142570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490814257550884908142575
00884908142570008849081425708849081425700884908142570

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableA sterile, 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. 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
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
50884908183912SLX Hemo-Cath®MC061405MC0614052026-03-21
50884908183943SLX Hemo-Cath®MC061404MC0614042026-03-21
50884908187620SLX Hemo-Cath®MC061424MBMC061424MB2026-03-21
50884908187637SLX HEMO-CATH®MC061425MBMC061425MB2026-03-21
30884908188456MICRO-STICK SETDMRAH190411DMRAH1904112026-02-19
30884908188463MICRO-STICK SETDMRAH190421DMRAH1904212026-02-19
50884908188474MICRO-STICK SETDMRAH190511DMRAH1905112026-02-19
50884908188481MICRO-STICK SETDMRAH190521DMRAH1905212026-02-19
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28036301MD280363012026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037201MD280372012026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037101MD280371012026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)MR28036304MR280363042026-02-17
50884908152703PRO-PICC® CTMD17035201MD170352012026-02-17
50884908154714PRO-PICC® CTMD17036201MD170362012026-02-17
50884908154721PRO-PICC® CTMD17036301MD170363012026-02-17
50884908160234PRO-PICC® CTMD17035101MD170351012026-02-17
50884908160258PRO-PICC® CTMD17034101MD170341012026-02-17
50884908174361PRO-PICC® CTMD17035105MD170351052026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMD17013101MD170131012026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMD17013105MD170131052026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450458426DuraMax®Merit Medical Systems, Inc.MSD2026-03-24
00884450458303DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458310DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458327DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458358DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
10884450458409DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458433DuraMaxMerit Medical Systems, Inc.MSD2026-03-20
10884450458218DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458362DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458386DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458416DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458232DuraMax®Merit Medical Systems, Inc.MSD2026-03-11
10884450793913BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-02-28
10884450795078DuraFlow™2Merit Medical Systems, Inc.MSD2026-02-26
10884450826888ProGuide™Merit Medical Systems, Inc.MSD2026-01-13
10884450793791BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-01-03
10884450794804DuraMax®Merit Medical Systems, Inc.MSD2026-01-03
10884450795115DuraFlow™2Merit Medical Systems, Inc.MSD2026-01-03
50884908185145MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
50884908185152MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
20884521811116RitusMozarc Medical US LLCMSD2025-11-27
10884450794828DuraMax®Merit Medical Systems, Inc.MSD2025-09-13
10884450795030DuraFlow™2Merit Medical Systems, Inc.MSD2025-09-06
10884450793777BioFlo DuraMax®Merit Medical Systems, Inc.MSD2025-09-04
10884450795122DuraFlow™2Merit Medical Systems, Inc.MSD2025-07-26
10884450793227BioFlo DuraMax®Merit Medical Systems, Inc.MSD2025-07-23
10884450820787CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-23
10884450827236ProGuide™Merit Medical Systems, Inc.MSD2025-07-16
10884450820794CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-11
50884908130503Hemo-Flow®Medical Components, Inc.MSD2025-06-26