FDA.reportPublic FDA data

Argyle

Primary DI
10192253013023
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888750513
Catalog number
8888750513
Device description
True content to be populated as part of rebranding
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
50192253013021PackageGS120In Commercial Distribution
10192253013023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225301302150192253013021
1019225301302310192253013023

GMDN Terms#

Term, Definition table
TermDefinition
Gastric lavage systemA device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris (e.g., toxic substances) from the stomach. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated liquid (e.g., saline); an extractor (frequently using vacuum) and controls for liquid temperature/pressure and rate of liquid infusion/withdrawal; and bags for the irrigation solution and waste. Most systems can deliver charcoal to the stomach for absorption of toxic substances; they are mainly used in emergency departments and for cleaning/evacuation of the stomach before some endoscopic and/or surgical procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
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
20889483131142Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29