FDA.reportPublic FDA data

Publix - Pen Needles with Remover 5mmx31g Mini

Primary DI
00041415068780
Brand
Publix - Pen Needles with Remover 5mmx31g Mini
Company
PUBLIX SUPER MARKETS, INC.
Model
AN 3850PX
Catalog number
AN 3850PX
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
20041415068784PackageGS124In Commercial Distribution
50041415068785PackageGS16In Commercial Distribution
00041415068780PrimaryGS10
00384703850009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004141506878420041415068784
5004141506878550041415068785
00041415068780000414150687800414150687800041415068780
00384703850009003847038500093847038500090384703850009

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
Needle Gauge31Gauge

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
863-688-7407xx@xx.xx

Regulatory Flags#

DUNS number
006922009
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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20041415426737PUBLIX84-3752016-09-24
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