FDA.reportPublic FDA data

Monoject

Primary DI
20884521023199
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
31323358
Catalog number
31323358
Device description
Monoject™ Safety In-Room Sharps Container, Transparent Yellow, 2 Gallon
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MMKContainer, sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521023199PackageGS112In Commercial Distribution
10884521023192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102319920884521023199
1088452102319210884521023192

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.

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
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
00840456219416JMUJMU DENTAL, INCMMK2026-03-09
00840456219423JMUJMU DENTAL, INCMMK2026-03-09
00840456219430JMUJMU DENTAL, INCMMK2026-03-09
00840456219447JMUJMU DENTAL, INCMMK2026-03-09
00840456219454JMUJMU DENTAL, INCMMK2026-03-09
00840456219461JMUJMU DENTAL, INCMMK2026-03-09
10197344176595MEDLINEMEDLINE INDUSTRIES, INC.MMK2026-03-04
01850062218184VerifinePromisemed Medical Devices Inc.MMK2025-11-20
01850062218221VerifinePromisemed Medical Devices Inc.MMK2025-11-20
01850062218290VerifinePromisemed Medical Devices Inc.MMK2025-11-20
06973696790378N/ANingbo HSCC Medical Technology Co.,LtdMMK2025-11-18
00850075610020Trademark Plastics, Inc.Trademark Plastics, Inc.MMK2025-08-25
20197344139733CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139740CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
10197344139767CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139771CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139795CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00197344139814CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139825CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139849CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00197344139869CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00850075255047Med-Tech ResourceMed-Tech Resource, LLCMMK2025-06-04
00850075610006Trademark Plastics, Inc. Trademark Plastics, Inc.MMK2025-05-31
10810100050471KBMEDKB Medical (group), Inc.MMK2025-05-21
10810100050488KBMEDKB Medical (group), Inc.MMK2025-05-21
00810132044144HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
00810132044151HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044165HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044172HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044189HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07