FDA.reportPublic FDA data

Smart Sense Pen Needles

Primary DI
00883967398133
Brand
Smart Sense Pen Needles
Company
KMART HOLDING CORPORATION
Model
700001338
Device description
"Sterile, Single-Use, 6-bevel pen needles, 31 Gauge, 8mm (5/16"") Length"
Published
2016-09-24
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10883967398130PackageGS120In Commercial Distribution
00883967398133PrimaryGS10
30883967398134Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088396739813010883967398130
00883967398133008839673981338839673981330883967398133
3088396739813430883967398134

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

Regulatory Flags#

DUNS number
131978533
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00072000758359Guaranteed Quality ProductsKD-1202016-09-20
00072000783894Guaranteed Quality ProductsKD-1812016-09-20
00072000764978Guaranteed Quality ProductsKD-16312016-09-20
00883967296910Image Essentials One Step Pregnancy TestFPPL2016-07-04
00883967296927Image Essentials One Step Pregnancy TestFPPL2016-07-04
00072000793138Smart Sense Early Result Pregnancy TestPLPL2016-07-04
00883967382231Smart Sense TamponsBKMGR182016-09-20
00883967382248Smart Sense TamponsBKMSGR182016-09-20
00883967382255Smart Sense TamponsBKMSGS182016-09-20
00883967382262Smart Sense TamponsBKMGS182016-09-20
00883967418343SMART SENSE TamponsBKMGR362017-05-02
00883967418350SMART SENSE TamponsBKMUR182017-05-02
00883967418367SMART SENSE TamponsBKMSGP362017-05-02
00883967418374SMART SENSE TamponBKMPS502017-05-02
00883967418381SMART SENSE TamponsBKMXC362017-05-02
10883967382238Smart Sense TamponsBKMGR182016-09-20
10883967382245Smart Sense TamponsBKMSGR182016-09-20
10883967382252Smart Sense TamponsBKMSGS182016-09-20
10883967382269Smart Sense TamponsBKMGS182016-09-20
10883967418340SMART SENSE TamponsBKMGR362017-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27