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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194346672837EquateEquate 2x12oz2026-06-23
00194346672844EquateEquate 12oz2026-06-23
00194346693122EquateWAL4545V4WAL4545V42026-06-02
00194346693139EquateWAL4245V4WAL4245V42026-06-02
00681131106108Equate5998092362026-02-25
00681131106092Equate5997602702026-02-25
00194346711994ReliOn1943467119942026-05-20
06974021412637equate sitz bathESB-012025-10-08
06974021412644equate shower benchESH-012025-10-08
00194346404131EquateEM47RP2026-05-08
00681131405898EquateHTD8813CHTD8815US2021-04-21
00194346614028Equate 3 UltraUA-8010BLEWMUA-8010BLEWM2026-05-04
00194346618057Equate 1 ProUA-4010WMUA-4010WM2026-05-04
00194346618064Equate 2 PlusUA-6010BLEWMUA-6010BLEWM2026-05-04
00194346404148EquateUHP252026-05-01
00194346404155EquateEM472026-05-01
00681131161602equate6811311616022025-05-14
00681131286213Equate6811312862132020-03-30
00194346067015EQUATE 682710647; 6587876092023-02-14
00681131116374EQUATE682710649, 6513554052022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253005127MonojectCardinal Health 200, LLCFMI2026-07-13
10192253005509MonojectCardinal Health 200, LLCFMI2026-07-13
00810011730809huahongTianjin Huahong Technology Co., Ltd.FMI2026-07-10
00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
20192253036999MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037125MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037132MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037156MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037194MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037200MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037255MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037262MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037279MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038269MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038283MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038290MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05