FDA.reportPublic FDA data

Argyle

Primary DI
10884527004669
Brand
Argyle
Company
Cardinal Health, Inc.
Model
43308
Catalog number
43308
Device description
Peripheral Inserted Central Catheter (PICC) Tray,No Catheter
Published
2015-10-06
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
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days
OWLPeripheral Catheter Insertion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527004669PackageGS15In Commercial Distribution
20884527004666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700466910884527004669
2088452700466620884527004666

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956477940CARDINAL HEALTHCardinal Health 200, LLCOWL2026-05-25
20809160517113MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OWL2026-03-23
10801741239356PowerPICC Sherlock 3CGBard Access Systems, Inc.LJS2026-03-11
10801741239363PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
10801741239370PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
30849884007474VYGONVygon CorporationOWL2026-03-06
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908152703PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154714PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154721PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160234PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160258PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908174361PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184117VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184124VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184278VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184285VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184292VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184308VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184315VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184322VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
10801741238830PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-02-11
30849884007320VYGONVygon CorporationOWL2026-02-11
50884908062415VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062446VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31