FDA.reportPublic FDA data

Permcath

Primary DI
20884521009933
Brand
Permcath
Company
Mozarc Medical US LLC
Model
8888169003
Device description
Chronic Silicone Oval Catheter Repair Kit Staggered Tip
Published
2015-08-31
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
KNZAccessories, a-v shunt

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K840424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840424000HEMOCATH REPAIR KITQuinton, Inc.1984-03-05KNZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521009933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100993320884521009933

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
Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Special Storage Condition, Specify00;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
10884521004801MAHURKAR88137930092015-10-22
10884521004832MAHURKAR88137930132015-10-22
10884521004887MAHURKAR88138160092015-10-22
10884521004894MAHURKAR88138170052015-10-22
10884521004931MAHURKAR88156680072016-10-13
10884521005006MAHURKAR88171430052015-10-22
10884521005020MAHURKAR88171460012015-10-22
10884521005037MAHURKAR88171460072015-10-22
10884521005150MAHURKAR88304150012015-10-22
10884521005174MAHURKAR88304150032015-10-22
10884521005303MAHURKAR88325390012015-10-22
10884521005341MAHURKAR88325390062015-10-22
20884521004877MAHURKAR88138160052015-10-22
20884521005317MAHURKAR88325390022015-10-22
10884521832930MAHURKAR88156680212022-11-03
10884521832985MAHURKAR88316630212022-11-03
10884521057098MAHURKAR88156680212015-10-22
10884521057234MAHURKAR88316630212015-10-22
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20

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
00884908144550DUO-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