FDA.reportPublic FDA data

Argyle

Primary DI
10192253050790
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8886864604
Catalog number
8886864604
Device description
Luki Tube Specimen Collection Device 20mL 6-1/4 in. (15.9 cm)
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDHCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And AspirationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253050797PackageGS112In Commercial Distribution
50192253050798PackageGS14In Commercial Distribution
10192253050790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225305079720192253050797
5019225305079850192253050798
1019225305079010192253050790

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic suction pumpAn electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure specifically for aspiration of the pleural cavity and/or mediastinum. It is a dedicated device intended to remove fluids (e.g., blood), secretions, and air to allow for the normal expansion/function of the lungs and/or mediastinum. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., catheter).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Total Volume0

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253024456Argyle888472450488847245042026-10-09
10192253024463Argyle888825860888882586082026-10-09
10192253050783Argyle888686430488868643042026-10-09
10192253050806Argyle888825736088882573602026-10-09
10192253050813Argyle888825737888882573782026-10-09
10192253050820Argyle888825738688882573862026-10-09
10192253050837Argyle888825746988882574692026-10-09
10192253050844Argyle888825747788882574772026-10-09
10192253050851Argyle888825748588882574852026-10-09
10192253050868Argyle888825752788882575272026-10-09
10192253050875Argyle888825753588882575352026-10-09
10192253050882Argyle888825755088882575502026-10-09
10885380214813DermaceaWD6112WD61122026-10-09
10885380214820DermaceaWD6113WD61132026-10-09
10885380214837DermaceaWD6114WD61142026-10-09
10885380214844DermaceaWD6115WD61152026-10-09
10885380214851DermaceaWD6116WD61162026-10-09
20885380157339FLEXAL88RT01XS88RT01XS2018-09-21
20885380157346FLEXAL88RT02S88RT02S2018-09-21
20885380157353FLEXAL88RT03M88RT03M2018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850082007100Aspiration TubingARMM INC.KDH2023-06-08
10850082007117Aspiration TubingARMM INC.KDH2023-06-08
10850082007124Aspiration TubingARMM INC.KDH2023-06-08
00850082007103Aspiration TubingARMM INC.KDH2023-06-08
00850082007110Aspiration TubingARMM INC.KDH2023-06-08
00850082007127Aspiration TubingARMM INC.KDH2023-06-08
10192253013016ArgyleCardinal Health 200, LLCKDH2022-10-26
10192253013023ArgyleCardinal Health 200, LLCKDH2022-10-26
50192253013014ArgyleCardinal Health 200, LLCKDH2022-10-26
50192253013021ArgyleCardinal Health 200, LLCKDH2022-10-26
00350770927961Aspiration CatheterAvanos Medical, Inc.KDH2019-09-10
10350770927968AVANOSAvanos Medical, Inc.KDH2019-09-10
00350770927749Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
00350770927756Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
00350770927800Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
10350770927746AVANOSAvanos Medical, Inc.KDH2019-07-27
10350770927753AVANOSAvanos Medical, Inc.KDH2019-07-27
10350770927807AVANOSAvanos Medical, Inc.KDH2019-07-27
00815277020084CuraplexBOUND TREE MEDICAL, LLCKDH2016-12-16
00827002165717SilberCOOK INCORPORATEDKDH2016-11-04
30884527000108ArgyleCardinal Health, Inc.KDH2016-10-14
10884527000104ArgyleCardinal Health, Inc.KDH2016-10-14
30884527000092ArgyleCardinal Health, Inc.KDH2016-10-13
20884527000095ArgyleCardinal Health, Inc.KDH2016-10-13
10889483131138Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483131145Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150047Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150054Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150061Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
20889483131135Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29