FDA.reportPublic FDA data

Insulin Syringes 1/2mL 29G x 1/2

Primary DI
50382909288518
Brand
Insulin Syringes 1/2mL 29G x 1/2
Company
Becton, Dickinson and Company Inc
Model
928851
Catalog number
928851
Device description
SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL
Published
2016-12-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024112000
K190054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024112000BD INSULIN SYRINGEBecton, Dickinson & CO2003-01-09FMF
K190054000BD Insulin SyringeBecton, Dickinson and Company2019-10-21FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50311917014895PackageGS15In Commercial Distribution
50382909288518PackageGS15In Commercial Distribution
00311917014890PrimaryGS10
00382903676712Unit of UseGS10
80382909288519Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5031191701489550311917014895
5038290928851850382909288518
00311917014890003119170148903119170148900311917014890
00382903676712003829036767123829036767120382903676712
8038290928851980382909288519

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Length12.7Millimeter
Needle Gauge29Gauge
Total Volume0.5Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-772-3212consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
047047543
Device count
100
DM exempt
false
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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