FDA.reportPublic FDA data

Permcath

Primary DI
10884521056121
Brand
Permcath
Company
Mozarc Medical US LLC
Model
8888680009
Device description
Pediatric Dual Lumen Catheter Repair Kit Staggered Tip
Published
2015-04-27
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
10884521056121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452105612110884521056121

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
Length28Centimeter

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
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
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