FDA.reportPublic FDA data

DDM - Short Pen Needles

Primary DI
00093351128424
Brand
DDM - Short Pen Needles
Company
DISCOUNT DRUG MART, INC.
Model
AN 3830DDM
Catalog number
AN 3830DDM
Device description
For use with injectors for the subcutaneous injection of approved drugs, including insulin
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
00761059831396PackageGS16In Commercial Distribution
00761059832393PackageGS124In Commercial Distribution
00093351128424PrimaryGS10
00384703830001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059831396007610598313967610598313960761059831396
00761059832393007610598323937610598323930761059832393
00093351128424000933511284240933511284240093351128424
00384703830001003847038300013847038300010384703830001

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
Length8Millimeter
Needle Gauge31Gauge

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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