Permcath

Primary DI
10884521009813
Brand
Permcath
Company
Mozarc Medical US LLC
Model
8815132001
Device description
Chronic Silicone Oval Catheter Staggered Tip with 2 Sealing Caps
Published
2014-09-01
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
FIQCannula, A-V Shunt

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K840415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840415000HEMOCATHQuinton, Inc.1984-04-20FIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521009813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452100981310884521009813

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
Length36Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5082618000Covidien.UDI@Covidien.com
+1 (508)261-8000covidien.udi@covidien.com
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
118997146
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20
10884521811287Ritus88137910012026-04-20
10884521811201Ritus88177910012024-10-21
10884521852822Argyle88884114472026-02-06
10884521005471MAHURKAR88881351662015-08-31
10884521006287MAHURKAR88881351342015-08-31
10884521006300MAHURKAR88881351352015-08-31
10884521006324MAHURKAR88881351362015-08-31
10884521006386MAHURKAR88881351632015-08-31
10884521006409MAHURKAR88881351642015-08-31
10884521006423MAHURKAR88881351652015-08-31
10884521006492MAHURKAR88881351932015-08-31
10884521006508MAHURKAR88881351942015-08-31
10884521006522MAHURKAR88881351962015-08-31
10884521006553MAHURKAR88881352432015-08-31
10884521006560MAHURKAR88881352442015-08-31
10884521070332Argyle88311730102015-10-22
10884521794733MAHURKAR88172320192020-04-12
10884521794740MAHURKAR88311730102020-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884521009827PermcathMozarc Medical US LLCFIQ2014-09-01