FDA.reportPublic FDA data

Duo-Flow®

Primary DI
50884908179946
Brand
Duo-Flow®
Company
Medical Components, Inc.
Model
MCDLT3500
Catalog number
MCDLT3500
Device description
11.5F X 12CM Duo-Flow® CATHETER FULL TRAY
Published
2024-07-04
Public version status
New
Distribution status
Not 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
KNZAccessories, a-v shunt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNZAccessories, A-V ShuntGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908179946PackageGS15Not in Commercial Distribution
00884908179941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490817994650884908179946
00884908179941008849081799418849081799410884908179941

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein 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 and may be radiopaque; 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
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
00884908175394Duo-Flow®Medical Components, Inc.KNZ2024-07-11
00884908175400Duo-Flow®Medical Components, Inc.KNZ2024-07-11
00884908175417Duo-Flow®Medical Components, Inc.KNZ2024-07-11
00884908175424Duo-Flow®Medical Components, Inc.KNZ2024-07-11
00884908179941Duo-Flow®Medical Components, Inc.KNZ2024-07-04
00884908179958Duo-Flow®Medical Components, Inc.KNZ2024-07-04
00884908179965Duo-Flow®Medical Components, Inc.KNZ2024-07-04
00884908179972Duo-Flow®Medical Components, Inc.KNZ2024-07-04
50884908179953Duo-Flow®Medical Components, Inc.KNZ2024-07-04
50884908179960Duo-Flow®Medical Components, Inc.KNZ2024-07-04
50884908179977Duo-Flow®Medical Components, Inc.KNZ2024-07-04
00884908175578Soft-Line® Duo-Flow®Medical Components, Inc.KNZ2024-05-11
50884908175573Soft-Line® Duo-Flow®Medical Components, Inc.KNZ2024-05-11
00884908162936Duo-Flow®Medical Components, Inc.KNZ2021-08-18
50884908162931Duo-Flow®Medical Components, Inc.KNZ2021-08-18
00884908144529DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
00884908144536DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
00884908144543DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
00884908144550DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
00884908144567DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
50884908144524DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
50884908144531DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
50884908144548DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
50884908144555DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
50884908144562DUO-FLOW®Medical Components, Inc.KNZ2019-07-23
00884908143171DUO-FLOW®Medical Components, Inc.KNZ2019-07-17
00884908143188DUO-FLOW®Medical Components, Inc.KNZ2019-07-17
00884908146240DUO-FLOW®Medical Components, Inc.KNZ2019-07-17
50884908143176DUO-FLOW®Medical Components, Inc.KNZ2019-07-17
50884908143183DUO-FLOW®Medical Components, Inc.KNZ2019-07-17