FDA.reportPublic FDA data

DUO-FLOW®

Primary DI
00884908144550
Brand
DUO-FLOW®
Company
Medical Components, Inc.
Model
DXTP98MT
Catalog number
DXTP98MT
Device description
9F X 20CM DUO-FLOW®DOUBLE LUMEN CATHETER SETLUMEN CATHETER
Published
2019-07-23
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
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
50884908144555PackageGS15In Commercial Distribution
00884908144550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490814455550884908144555
00884908144550008849081445508849081445500884908144550

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.

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
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
50884908179946Duo-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
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