FDA.reportPublic FDA data

BD Autoshield Duo Safety Pen Needle, 8MM

Primary DI
50382903295154
Brand
BD Autoshield Duo Safety Pen Needle, 8MM
Company
Becton, Dickinson and Company Inc
Model
329515
Catalog number
329515
Device description
PEN NEEDLE SAFETY DUO 30G X 8MM
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
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
K110703000
K223286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110703000BD AUTOSHIELD DUO PEN NEEDLEBecton, Dickinson and Company2011-07-27FMI
K223286000BD AutoShield Duo™ Pen NeedleBecton, Dickinson and Company2022-12-28FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903295154PackageGS18In Commercial Distribution
00382903295159PrimaryGS10
00382903673933Unit of UseGS10
80382903295155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290329515450382903295154
00382903295159003829032951593829032951590382903295159
00382903673933003829036739333829036739330382903673933
8038290329515580382903295155

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter
Length8Millimeter
Needle Gauge30Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047047543
Device count
100
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903234875BD Home Sharps Collector3234873234872016-08-03
30382903249061BD Veo3249063249062018-02-23
30382903249078BD Veo3249073249072018-02-23
30382903249085BD Veo3249083249082018-02-23
30382903282785BD Ultra-Fine3282783282782016-08-03
30382903282792BD Ultra-Fine3282793282792016-08-03
30382903282808BD Ultra-Fine3282803282802016-08-03
30382903282891BD Ultra-Fine3282893282892016-08-03
30382903282907BD Ultra-Fine3282903282902016-08-03
30382903282914BD Ultra-Fine3282913282912016-08-03
30382903294108BD Micro-Fine3294103294102016-08-03
30382903294122BD Micro-Fine3294123294122016-08-03
30382903294207BD Micro-Fine3294203294202016-08-03
30382903294245BD Micro-Fine3294243294242016-08-03
30382903294610BD Micro-Fine3294613294612016-08-03
30382903294658BD Micro-Fine3294653294652016-08-03
00382903249091BD Veo3249093249092018-02-23
00382903249107BD Veo3249103249102018-02-23
00382903249114BD Veo3249113249112018-02-23
00382903249121BD Veo3249123249122018-02-23

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