FDA.reportPublic FDA data

"10"" Dialysis Tubing Extensions (Pair) "

Primary DI
16641670000825
Brand
"10"" Dialysis Tubing Extensions (Pair) "
Company
Cardiomed Supplies Inc
Model
1.5
Catalog number
17-088
Device description
"10"" Dialysis Tubing Extensions (Pair) are shot lengths of hemodialysis blood tubing with a male swivel luer lock connector on the one end and female luer lock connector on the other. A small pinch clamp is also provided on each tube segment. Protective caps are secured to each end to prevent product contamination and maintain sterility when the sterile pouch is opened. "
Published
2020-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833112000TUBING FOR CARDIOPULMONARY BYPASSCardio Med Supplies, Inc.1983-11-28DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36641670000836PackageGS150In Commercial Distribution
16641670000825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167000083636641670000836
1664167000082516641670000825

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Regulatory Flags#

DUNS number
240623124
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36641670001314Adult Heart Cooling Jacket2.417-2602021-04-21
36641670001338Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
36641670001352Pediatric Heart Cooling Jacket2.017-2622021-04-21
36641670011528rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
36641670019241Drop-It™ Quick Release Needle Holders1.145502021-04-21
16641670001303Adult Heart Cooling Jacket2.417-2602021-04-21
16641670001327Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
16641670001341Pediatric Heart Cooling Jacket2.017-2622021-04-21
16641670011517rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
16641670019230Drop-It™ Quick Release Needle Holders1.145502021-04-21
366416700041793/8'' x 1/4'' x 3/8'' Y Connector2.9C-6602020-12-02
366416700041931/2'' x 3/8'' x 3/8'' Y Connector2.8C-6612020-12-02
366416700042163/8'' x 1/4'' x 1/4'' Y Connector2.0C-6622020-12-02
366416700042301/2'' x 3/8'' x 1/2'' Y Connector2.4C-6632020-12-02
366416700042541/4'' Y Connector w/L.L.2.6C-6642020-12-02
366416700042783/8'' Y Connector w/L.L.2.6C-6652020-12-02
366416700042921/2'' Y Connector w/L.L.1.4C-6662020-12-02
366416700043153/16'' Y Connector w/L.L.1.5C-6672020-12-02
366416700043393/8'' x 1/4'' x 3/8'' Y Connector w/L.L.1.3C-6682020-12-02
366416700043531/2'' x 3/8'' x 3/8'' Y Connector w/L.L.1.6C-6692020-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00199150083855NAMEDTRONIC, INC.DWF2026-06-08
00199150083992NAMEDTRONIC, INC.DWF2026-06-08
00199150084180NAMEDTRONIC, INC.DWF2026-06-08
00824846000020NAMEDTRONIC, INC.DWF2026-06-08
00824846000983NAMEDTRONIC, INC.DWF2026-06-08
00824846001027NAMEDTRONIC, INC.DWF2026-06-08
00824846001041NAMEDTRONIC, INC.DWF2026-06-08
00824846001065NAMEDTRONIC, INC.DWF2026-06-08
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30
00199150083800NAMEDTRONIC, INC.DWF2026-05-30
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11