FDA.reportPublic FDA data

Argyle

Primary DI
50192253013014
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888750018
Catalog number
8888750018
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
OTC
false
Sterile
false
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
50192253013014PackageGS120In Commercial Distribution
10192253013016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225301301450192253013014
1019225301301610192253013016

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.

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

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
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