FDA.reportPublic FDA data

APmedical

Primary DI
18013183096752
Brand
APmedical
Company
ABM ITALIA SPA
Model
FGCS3Y001 CS 3Y
Device description
(3 Qt/3 Lt CHEMO USA YELL Disposable Square Container (50 EA/Case) w/White Lid)
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MMKContainer, Sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071517000AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.A.B.M. Italia S.P.A2008-04-02MMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18013183096752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1801318309675218013183096752

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA device designed as a container to allow 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 be incineration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
338493631
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08013183096403APmedicalFGAP5Q4RS001 AP5.4R2016-08-18
08013183096410APmedicalFGAP5Q4WS001 AP5.4W2016-08-18
08013183096427APmedicalFGAP5Q4YS001 AP5.4Y2016-08-18
08013183096434APmedicalFGCS2NRS001 CS 2NR 2016-08-18
08013183096441APmedicalFGCS2NYS001 CS 2NY2016-08-18
08013183096458APmedicalFGCS3RS001 CS 3R2016-08-18
08013183096465APmedicalFGCS3YS001 CS 3Y2016-08-18
08013183096472APmedicalFGCS4RS001 CS 4R2016-08-18
08013183096489APmedicalFGCS4YS001 CS 4Y2016-08-18
08013183096496APmedicalFGCS5BRS001 CS 5BR2016-08-18
08013183096502APmedicalFGCS5BYS001 CS 5BY2016-08-18
08013183096519APmedicalFGPBS0.8RS001 PBS 0.8R2016-08-18
08013183096526APmedicalFGPBS0.8YS001 PBS 0.8Y2016-08-18
08013183096533APmedicalFGPBS1.5RS001 PBS 1.5R2016-08-18
08013183096540APmedicalFGPBS1.5YS001 PBS 1.5Y2016-08-18
08013183096557APmedicalFGPBS12RS001 PBS 12R2016-08-18
08013183096564APmedicalFGPBS12YS001 PBS 12Y2016-08-18
08013183096571APmedicalFGPBS2RS001 PBS 2R 2016-08-18
08013183096588APmedicalFGPBS2YS001 PBS 2Y2016-08-18
08013183096595APmedicalFGPBS5RS001 PBS 5R 2016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253005660NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005684NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005691NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005707NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005714NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005721NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005738NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005745NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005752NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005769NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10197344118496MEDLINEMEDLINE INDUSTRIES, INC.MMK2024-11-28
16971292007088AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
16971292007095AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
10884521023192MonojectCardinal Health 200, LLCMMK2023-12-21
10884521023239MonojectCardinal Health 200, LLCMMK2023-12-21
20884521023113MonojectCardinal Health 200, LLCMMK2023-12-21
16947462492404GongdongZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.MMK2023-09-07
10884521141407SharpSafetyCardinal Health, Inc.MMK2023-08-23
09337363001834BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
09337363001841BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
10884521023062Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10884521023338SharpSafetyCardinal Health, Inc.MMK2023-02-06
20884521076805Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10080196282654MedlineMEDLINE INDUSTRIES, INC.MMK2022-11-30
10612479209340McKessonMCKESSON MEDICAL-SURGICAL INC.MMK2022-07-28
10073088161854BEMISBemis de México, S.A. de C.V.MMK2022-04-07
10888277171022MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171107MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171145MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277408005MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2021-10-01