FDA.reportPublic FDA data

Symetrex

Primary DI
M967R20028
Brand
Symetrex
Company
Phase One Medical LLC
Model
R20028
Catalog number
R20028
Device description
Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 28 cm
Published
2015-09-25
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M967R20028PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15.5French
Length28Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-740-0076sales@phase-one.us

Regulatory Flags#

DUNS number
131502671
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
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
M967R20019SymetrexR20019R200192015-09-25
M967R20023SymetrexR20023R200232015-09-25
M967R20033SymetrexR20033R200332015-09-25
M967S20019SymetrexS20019S200192015-09-25
M967S20023SymetrexS20023S200232015-09-25
M967S20028SymetrexS20028S200282015-09-25
M967S20033SymetrexS20033S200332015-09-25
M967S20037SymetrexS20037S200372015-09-25
M967S20042SymetrexS20042S200422015-09-25

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Primary DI, Brand, Company table
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00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
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