FDA.reportPublic FDA data

Argyle

Primary DI
20884521009988
Brand
Argyle
Company
Mozarc Medical US LLC
Model
8818782001
Device description
Acute Catheter Accessory,Y-Adapter
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFJCATHETER, SUBCLAVIAN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFJCatheter, SubclavianGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521009981PackageGS125In Commercial Distribution
20884521009988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452100998110884521009981
2088452100998820884521009988

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
118997146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521795303MAHURKAR88187820012020-04-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902197129ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
10801902197136ARROWTELEFLEX INCORPORATEDLFJ2026-07-29
00884908183894HEMO-CATH® SILICONEMedical Components, Inc.LFJ2026-03-28
00884908183900HEMO-CATH® SILICONEMedical Components, Inc.LFJ2026-03-28
00884908183917SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908183948SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908187625SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
00884908187632SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
50884908183912SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908183943SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187620SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187637SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
10801902223033ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223040ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902223057ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223036ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223043ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223050ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
10801902212211ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
20801902212218ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
10801902190373ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
20801902190370ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
00884908175226SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175233SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175240SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
00884908175257SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28
50884908175221SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175238SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175245SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175252SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28