FDA.reportPublic FDA data

BEMIS

Primary DI
10073088148770
Brand
BEMIS
Company
Bemis de México, S.A. de C.V.
Model
102 040
Catalog number
102 040
Device description
2 GALLLON YELLOW 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
10073088148770PrimaryGS10
00073088148773Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007308814877010073088148770
00073088148773000730881487730730881487730073088148773

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
589153555
Device count
30
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10073088149548Bemis300430042016-09-24
10073088148855BEMIS108 040108 0402016-09-24
10073088149395BEMIS208 004208 0042016-09-24
10073088161854BEMIS175 030D175 030D2022-04-07
10073088148640BEMIS100 030 100 0302016-09-24
10073088148657BEMIS100 040100 0402016-09-24
10073088149272BEMIS175 020175 0202016-09-24
10073088149289BEMIS175 030175 0302016-09-24
10073088149296BEMIS175 040175 0402016-09-24
10073088149364BEMIS202 004202 0042016-09-24
10073088149371BEMIS202 040202 0402016-09-24
10073088149654BEMIS303 040303 0402016-09-24
10073088148763BEMIS102 030102 0302016-09-24
10073088148848BEMIS108 030108 0302016-09-24
10073088149685BEMIS333 020333 0202016-09-24
10073088149692BEMIS333 030333 0302016-09-24
10073088149708BEMIS333 040333 0402016-09-24
10073088150704BEMIS208 040208 0402016-09-24
10073088149630BEMIS303 020303 0202016-09-24
10073088149647BEMIS303 030303 0302016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26
06972857295677contour comfort Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCFMI2026-08-13
10192253004243MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004250MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004304MonojectCardinal Health 200, LLCMMK2026-08-03
10801902215168ARROWTELEFLEX INCORPORATEDFMI2026-08-03
00301691863012NOVOFINE PLUS 29GNOVO NORDISK INC.FMI2026-07-31
00301691863500NOVOFINE PLUS 29GNOVO NORDISK INC.FMI2026-07-31
00301691863906NovoFine® Plus 29GNOVO NORDISK INC.FMI2026-07-31
10192253004458MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004465MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004472MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004915MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005066MonojectCardinal Health 200, LLCFMI2026-07-31
10192253005295MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005516MonojectCardinal Health 200, LLCFMI2026-07-31
10192253005622MonojectCardinal Health 200, LLCMMK2026-07-31
00810094578053Curaplex®BOUND TREE MEDICAL, LLCFMI2026-07-30
10801902215175ARROWTELEFLEX INCORPORATEDFMI2026-07-29
10801902215182ARROWTELEFLEX INCORPORATEDFMI2026-07-29
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