FDA.reportPublic FDA data

DDM - Original Pen Needles

Primary DI
00093351128417
Brand
DDM - Original Pen Needles
Company
DISCOUNT DRUG MART, INC.
Model
AN 3829DDM
Catalog number
AN 3829DDM
Device description
Discount Drug Mart Original Pen Needles with Remover - 12mm x 29G
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K152339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152339000Unifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd.2016-06-24FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00761059820390PackageGS16In Commercial Distribution
00761059821397PackageGS124In Commercial Distribution
00093351128417PrimaryGS10
00384703829005Unit of UseGS10
00384703829008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059820390007610598203907610598203900761059820390
00761059821397007610598213977610598213970761059821397
00093351128417000933511284170933511284170093351128417
00384703829005003847038290053847038290050384703829005
00384703829008003847038290083847038290080384703829008

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
Length12Millimeter
Needle Gauge29Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-899-7353xx@xx.xx

Regulatory Flags#

DUNS number
047741335
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00093351027796Discount Drug Mart Food Fair0933510277962020-08-17
00093351027819Discount Drug Mart Food Fair0933510278192020-08-17
00093351039904DISCOUNT DRUG MARTDDM4145DDM41452024-11-25
80093351039900DISCOUNT DRUG MARTDDM4145DDM41452024-11-25
00093351031854Discount Drug Mart Food Fair0933510318542020-09-14
00093351118302Discount Drug Mart Food Fair0933511183022020-08-17
00093351118364Discount Drug Mart Food Fair0933511183642020-08-17
00093351124266Discount Drug Mart Food Fair0933511242662020-08-17
00093351124273Discount Drug Mart Food Fair0933511242732020-08-17
00093351124280Discount Drug Mart Food Fair0933511242802020-08-17
00093351113437Discount Drug Mart One Step Pregnancy TestFPPL2016-06-30
00093351120343Discount Drug Mart Early Result Pregnancy TestPLPL2016-06-30
00093351029929Discount Drug Mart Unifine Pentips PlusAN 3860DDM2023-06-20
00093351017049Discount Drug Mart Food Fair0933510170492020-03-02
00093351009365Discount Drug Mart UniletAT 0925DDM2023-03-03
00761059567394Discount Drug Mart UniletAT 0925DDM2023-03-03
00093351009358Discount Drug Mart UniletAT 0465DDM2023-02-27
00093351015328Discount Drug Mart AT 1028DDM2023-02-27
00093351027291Discount Drug Mart UniletAT 0585DDM2023-02-27
00761059577393Discount Drug Mart UniletAT 0465DDM2023-02-27

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