FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594077372
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA40IKCTA
Catalog number
SBA40IKCTA
Device description
IRRIGATION KIT
Published
2021-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBQCATHETER, CONTINUOUS IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBQCatheter, Continuous IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594077370PackageGS110In Commercial Distribution
10195594077372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559407737050195594077370
1019559407737210195594077372

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849296009898WelmedWELMED INC.GBQ2026-02-15
00849296009911WelmedWELMED INC.GBQ2026-02-15
00849296014939WelmedWELMED INC.GBQ2026-02-15
00849296014946WelmedWELMED INC.GBQ2026-02-15
00849296015035WelmedWELMED INC.GBQ2026-02-15
00849296015042WelmedWELMED INC.GBQ2026-02-15
00849296015059WelmedWELMED INC.GBQ2026-02-15
00849296015066WelmedWELMED INC.GBQ2026-02-15
00849296015073WelmedWELMED INC.GBQ2026-02-15
00849296015080WelmedWELMED INC.GBQ2026-02-15
00849296018203WelmedWELMED INC.GBQ2026-02-15
00849296018210WelmedWELMED INC.GBQ2026-02-15
00840106905102PERMA PUREPERMA PURE LLCGBQ2024-11-05
00886333220977Drainage BagARGON MEDICAL DEVICES, INC.GBQ2022-07-20
20886333220971Drainage BagARGON MEDICAL DEVICES, INC.GBQ2022-07-20
00886333227198SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227204SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227211SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227228SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227235SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227242SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227259SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227266SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227192SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227208SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227215SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227222SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227239SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227246SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227253SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14