FDA.reportPublic FDA data

Sharps Away

Primary DI
B4501380Y0
Brand
Sharps Away
Company
Solutions
Model
1380Y
Catalog number
1380Y
Device description
8-gallon sharps container yellow
Published
2017-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943765000SHARPS AWAYBiomedical Waste Systems, Inc.1995-07-10FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4501380Y0PrimaryHIBCC0

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 Volume8Gallon

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028492788
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B4501320H0Sharps Away1320H1320H2017-09-22
B4501320V0Sharps Away1320V1320V2017-09-22
B4501330H0Sharps Away1330H1330H2017-09-22
B4501330V0Sharps Away1330V1330V2017-09-22
B4501380V0Sharps Away1380V1380V2017-09-22

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