FDA.reportPublic FDA data

Bio-Flex® Extension Set

Primary DI
50884908005191
Brand
Bio-Flex® Extension Set
Company
Medical Components, Inc.
Model
BF11A
Device description
ARTERIAL Bio-Flex® EXTENSION SET AND INJECTION CAP
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
50884908005191PackageGS110In Commercial Distribution
00884908005196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490800519150884908005191
00884908005196008849080051968849080051960884908005196

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