FDA.reportPublic FDA data

BEMIS

Primary DI
10073088151039
Brand
BEMIS
Company
BEMIS MANUFACTURING COMPANY
Model
102 020
Catalog number
102 020
Device description
2 GALLON BEIGE SHARPS CONTAINER
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen
MMKContainer, Sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K965248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965248000BEMIS TWO GALLON SHARPS CONTAINERBemis Mfg. Co.1997-02-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073088151039PrimaryGS10
00073088151032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007308815103910073088151039
00073088151032000730881510320730881510320073088151032

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Gallon

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006072078
Device count
30
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10073088161755Bemis7209824-J7209824-J2021-06-17
10073088165296BemisPAL-SC-3000PAL-SC-30002025-02-07
10073088165302BEMISPAL-SC-2000PAL-SC-20002025-02-07
00073088165299BemisPAL-SC-3000PAL-SC-30002025-02-07
00073088165305BEMISPAL-SC-2000PAL-SC-20002025-02-07
10073088150414Bemis5350105350102016-09-24
10073088150490Bemis5384105384102016-09-24
10073088162660BEMIS6354106354102024-11-25
00073088162663BEMIS6354106354102024-11-25
10073088162646BEMIS6244106244102024-10-23
00073088162649BEMIS6244106244102024-10-23
10073088162653BEMIS6344106344102024-10-15
10073088162677BEMIS6364106364102024-10-15
00073088162656BEMIS6344106344102024-10-15
00073088162670BEMIS6364106364102024-10-15
20073088150565BEMIS8002 055 N8002 055 N 2024-10-15
10073088150421Bemis5355105355102016-09-24
10073088150476Bemis5381105381102016-09-24
10073088150483Bemis5382105382102016-09-24
10073088164244BEMIS8002004L108002004L102024-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253004489SharpSafetyCardinal Health 200, LLCMMK2026-09-24
10192253004502MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004557MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004571MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004632SharpSafetyCardinal Health 200, LLCMMK2026-09-24
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10192253005080MonojectCardinal Health 200, LLCMMK2026-09-24
10192253005493MonojectCardinal Health 200, LLCMMK2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04