FDA.reportPublic FDA data

BD Sharps Collector

Primary DI
00382903054268
Brand
BD Sharps Collector
Company
BECTON, DICKINSON AND COMPANY
Model
305426
Catalog number
305426
Device description
SHARPS COLL NEXT GEN 5.4QT RED 12/PACK
Published
2017-03-20
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943141000B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORSMed-Safe Systems, Inc.1994-11-07FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903054263PackageGS112In Commercial Distribution
00382903054268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290305426350382903054263
00382903054268003829030542683829030542680382903054268

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA hard-walled container designed for 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 by incineration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
1
Lot or batch
true

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00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
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00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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