FDA.reportPublic FDA data

H.E.B. Unifine Pentips Plus

Primary DI
00041220520688
Brand
H.E.B. Unifine Pentips Plus
Company
H. E. BUTT GROCERY COMPANY
Model
AN 1830HEB
Device description
HEB Unifine Pentips Plus pen needles, 8mm x 31G
Published
2023-06-20
Public version status
New
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
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
50041220520683PackageGS150In Commercial Distribution
00041220520688PrimaryGS10
00384703830004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5004122052068350041220520683
00041220520688000412205206880412205206880041220520688
00384703830004003847038300043847038300040384703830004

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
007924756
Device count
30
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
00041220048632H-E-B0412200486322020-07-27
00041220865468H-E-B inControlG202016-12-13
00197870203805H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00197870203812H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00633472000690H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00041220569311H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575763H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575770H.E.B Advanced Early Result Pregnancy Test2021-06-25
00041220575794H.E.B Advanced Early Result Pregnancy Test2021-06-13
00197870203843H.E.BSix Days Sooner Pregnancy TestN/A2025-11-12
00197870203836H.E.BSix Days Sooner Pregnancy TestN/A2025-11-11
00041220723478H.E.B Advanced One Step Pregnancy Test2021-06-13
00197870203829H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00633472000683H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00041220245970H-E-B156-757-000156-757-0002016-09-12
00041220924837H-E-B156-878-000156-878-0002016-09-12
00041220823222HEB jelly PERSONAL LUBRICANT7W9261JC12021-12-08
00041220524556H.E.B Digital & Early Result Pregnancy Test 2021-06-25
00041220524563H.E.B Digital Pregnancy Test 2021-06-25
00197870071480H.E.BHEB DIG Wide-Tip & VIS PinkN/A2025-03-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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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
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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