FDA.reportPublic FDA data

Amecath Y split catheter

Primary DI
06221139123956
Brand
Amecath Y split catheter
Company
Ameco Medical Industries
Model
PYDLC-15.535-KPC
Device description
Permthane Y split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 35 Cm total length 40 Cm
Published
2014-07-31
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
MSDCatheter, Hemodialysis, Implanted

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131814000AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETERAmeco Medical Industries2013-07-26MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06221139123956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06221139123956062211391239566221139123956

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15.5French
Length35Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2038804091ray.k@arazygroup.com

Regulatory Flags#

DUNS number
565404779
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06221139070045Amecath X split catheterPXDLC-1431-K2019-08-22
06221139058722Amecath dual lumen catheterPDLC-1216-K2014-07-31
06221139058739Amecath dual lumen catheterPDLC-1219-K2014-07-31
06221139058746Amecath dual lumen catheterPDLC-1419-K2014-07-31
06221139058753Amecath dual lumen catheterPDLC-1423-K2014-07-31
06221139058760Amecath dual lumen catheterPDLC-1427-K2014-07-31
06221139058777Amecath dual lumen catheterPDLC-1431-K2014-07-31
06221139058784Amecath dual lumen catheterPDLC-1435-K2014-07-31
06221139058791Amecath dual lumen catheterPDLC-1450-K2014-07-31
06221139058890Amecath dual lumen catheterPDLC-1216-KPC2014-07-31
06221139058906Amecath dual lumen catheterPDLC-1219-KPC2014-07-31
06221139058913Amecath dual lumen catheterPDLC-1419-KPC2014-07-31
06221139058920Amecath dual lumen catheterPDLC-1423-KPC2014-07-31
06221139058937Amecath dual lumen catheterPDLC-1427-KPC2014-07-31
06221139058944Amecath dual lumen catheterPDLC-1431-KPC2014-07-31
06221139058951Amecath dual lumen catheterPDLC-1435-KPC2014-07-31
06221139058968Amecath dual lumen catheterPDLC-1450-KPC2014-07-31
06221139059064Amecath X split catheterPXDLC-1216-K2014-07-31
06221139059071Amecath X split catheterPXDLC-1219-K2014-07-31
06221139059088Amecath X split catheterPXDLC-1419-K2014-07-31

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00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
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