FDA.reportPublic FDA data

Monoject

Primary DI
50192253035542
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881560141
Catalog number
8881560141
Device description
60 mL Syringe Catheter Tip
Published
2024-11-11
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
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253035542PackageGS15In Commercial Distribution
20192253035541PrimaryGS10
10192253035544Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303554250192253035542
2019225303554120192253035541
1019225303554410192253035544

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume60Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
20
DM exempt
false
Premarket exempt
true
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
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
00861092002606CeaLogic Ratio Applicator KitRECIBIO, INC.KYZ2026-03-01
00850027492995NavägeRhinosystems, Inc.KYZ2026-02-23
50192253068854MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068860MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068885MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068892MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253007449MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007487MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007518MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007531MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007555MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007730MonojectCardinal Health 200, LLCKYZ2025-12-15
00850063139441Neil Medical Group Neil Medical GroupKYZ2025-12-08
05413765580970RECOTHROM SPRAY KITBAXTER HEALTHCARE CORPORATIONKYZ2025-12-01
50198956194647CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
50198956181548CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
00810180841931Syringes without Needle, Non-Toxic, Luer Slip, 20 ML Dynarex CorporationKYZ2025-05-30
00810180841948Syringes without Needle, Non-Toxic, Luer Slip, 60 MLDynarex CorporationKYZ2025-05-30
10661392002255LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002262LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002842LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002859LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002927LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004440LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004457LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004464LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008394LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008400LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008417LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008424LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16