Home GUDID 20884521024295 Argyle
Primary DI 20884521024295
Brand Argyle
Company Covidien LP
Model 8815544002
Catalog number 8815544002
Device description Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,12 Fr/Ch (4.0 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
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FKO CATHETER, PERITONEAL DIALYSIS, SINGLE USE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20884521024295 Package GS1 5 In Commercial Distribution 10884521024298 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521024295 20884521024295 10884521024298 10884521024298
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of sterile, 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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 12 French
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 ;AVOID DIRECT SUNLIGHT
Regulatory Flags# DUNS number 058614483 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884521811164 Ritus Mozarc Medical US LLC FKO 2026-04-20 10885403108327 n/a CAREFUSION 2200, INC FKO 2017-06-12 50885403108325 n/a CAREFUSION 2200, INC FKO 2017-06-12 10884521024281 Argyle Mozarc Medical US LLC FKO 2016-09-24 10884521024298 Argyle Mozarc Medical US LLC FKO 2016-09-24 10884521024311 Argyle Mozarc Medical US LLC FKO 2016-09-24 20884521024288 Argyle Covidien LP FKO 2016-09-24 20884521024301 Argyle Covidien LP FKO 2016-09-24 20884521024318 Argyle Covidien LP FKO 2016-09-24 H67140005070 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 H67140005170 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 H67140005270 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 H67140005370 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 H67140005470 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 H67140005570 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 H67140005670 DIALY-NATE UTAH MEDICAL PRODUCTS, INC. FKO 2016-09-23 00898021000068 Alcavis 50 Angelini Pharma Inc. FKO 2016-08-29 20898021000062 Alcavis 50 ANGELINI PHARMA INC. FKO 2016-08-29 00884450170021 Flex-Neck® Merit Medical Systems, Inc. FKO 2015-10-30 10884450170028 Flex-Neck® Merit Medical Systems, Inc. FKO 2015-10-30 00852250006017 Lifemed Acute Tenckhoff Peritoneal Catheter LIFEMED OF CALIFORNIA FKO 2015-10-06 10852250006014 Lifemed Acute Tenckhoff Peritoneal Catheter LIFEMED OF CALIFORNIA FKO 2015-10-06 00852250006079 Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter LIFEMED OF CALIFORNIA FKO 2015-10-06
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