FDA.reportPublic FDA data

Argyle

Primary DI
10884521024311
Brand
Argyle
Company
Mozarc Medical US LLC
Model
8815544010
Device description
Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,16 Fr/Ch (5.3 mm)
Published
2016-09-24
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
FKOCATHETER, PERITONEAL DIALYSIS, SINGLE USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKOCatheter, Peritoneal Dialysis, Single UseGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521024318PackageGS15In Commercial Distribution
10884521024311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102431820884521024318
1088452102431110884521024311

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Contacts#

Phone, Email table
PhoneEmail
+39053529111RegulatoryOperations@mozarcmedical.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
10884521795303MAHURKAR88187820012020-04-12
20884521009988Argyle88187820012015-10-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521811164RitusMozarc Medical US LLCFKO2026-04-20
10885403108327n/aCAREFUSION 2200, INCFKO2017-06-12
50885403108325n/aCAREFUSION 2200, INCFKO2017-06-12
10884521024281ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024298ArgyleMozarc Medical US LLCFKO2016-09-24
20884521024288ArgyleCovidien LPFKO2016-09-24
20884521024295ArgyleCovidien LPFKO2016-09-24
20884521024301ArgyleCovidien LPFKO2016-09-24
20884521024318ArgyleCovidien LPFKO2016-09-24
H67140005070DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005170DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005270DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005370DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005470DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005570DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005670DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
00898021000068Alcavis 50Angelini Pharma Inc.FKO2016-08-29
20898021000062Alcavis 50ANGELINI PHARMA INC.FKO2016-08-29
00884450170021Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
10884450170028Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
00852250006017Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
10852250006014Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
00852250006079Lifemed Pediatric Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06