FDA.reportPublic FDA data

APmedical

Primary DI
00875160189366
Brand
APmedical
Company
ABM ITALIA SPA
Model
FGAP30MRS001 AP30MR
Device description
(8 Gal SHARPS USA RED Disposable Container w/Flat/Mono Lid) Single EA
Published
2016-08-18
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
00875160189366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875160189366008751601893668751601893660875160189366

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
10192253004205MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004410MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004540MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004588MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004625SharpSafetyCardinal Health 200, LLCMMK2026-07-13
10192253004885MonojectCardinal Health 200, LLCMMK2026-07-13
00827989008250SharpSafetyHealth Care Logistics, Inc.MMK2026-07-10
10192253004649MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004656MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004663MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004700MonojectCardinal Health 200, LLCMMK2026-07-09
MHC18601502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18601552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
00768627017275Norco Sharps ContainerNORTH COAST MEDICAL, INC.MMK2026-06-01
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