FDA.reportPublic FDA data

Argyle

Primary DI
50192253003763
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888590224
Catalog number
8888590224
Device description
Left Ventricular Sump Vent Catheter, Catheter Retention Ring, (6.7 mm) x 20 in. (51 cm)
Published
2025-01-28
Public version status
New
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
CodeName
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253003763PackageGS110In Commercial Distribution
10192253003765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300376350192253003763
1019225300376510192253003765

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac ventriculography catheterA flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introduced into a peripheral blood vessel and its distal tip is placed in the left or right ventricle according to the desired ventriculography. Left ventriculography is used to assess impairment of the left ventricle, the presence of ventricular aneurysms or septal defects, or to assess the mitral valve. Right ventriculography is used mostly to asses congenital heart disease. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge20French
Length20Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150081745NAMEDTRONIC, INC.DWF2026-05-23
00199150081035NAMEDTRONIC, INC.DWF2026-05-22
00199150081042NAMEDTRONIC, INC.DWF2026-05-22
00199150081707NAMEDTRONIC, INC.DWF2026-05-22
00199150081738NAMEDTRONIC, INC.DWF2026-05-22
00199150082902NAMEDTRONIC, INC.DWF2026-05-22
20199150073652NAMEDTRONIC, INC.DWF2026-03-22
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20199150073690NAMEDTRONIC, INC.DWF2026-03-22
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20763000990286NAMEDTRONIC, INC.DWF2026-03-16
00199150071623NAMEDTRONIC, INC.DWF2026-03-07
20199150071917NAMEDTRONIC, INC.DWF2026-03-07
00199150071920NAMEDTRONIC, INC.DWF2026-03-07
00199150071937NAMEDTRONIC, INC.DWF2026-03-07
00199150071944NAMEDTRONIC, INC.DWF2026-03-07
20199150072020NAMEDTRONIC, INC.DWF2026-03-07
00199150072033NAMEDTRONIC, INC.DWF2026-03-07
00199150072040NAMEDTRONIC, INC.DWF2026-03-07