FDA.reportPublic FDA data

Pen Needle

Primary DI
00681131386814
Brand
Pen Needle
Company
WAL-MART STORES, INC.
Model
320616
Catalog number
320616
Device description
"ReliOn Pen Needles 8mm x 31 Gauge (5/16"" x 0.25mm) Pen Needles 50 count"
Published
2023-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K213478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213478000BD Pen NeedleBecton, Dickinson and Company2022-06-28FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903206167PackageGS118In Commercial Distribution
00681131386814PrimaryGS10
80382903206168Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290320616750382903206167
00681131386814006811313868146811313868140681131386814
8038290320616880382903206168

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051957769
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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