FDA.reportPublic FDA data

H.E.B. Unifine Pentips

Primary DI
00041220520336
Brand
H.E.B. Unifine Pentips
Company
H. E. BUTT GROCERY COMPANY
Model
AN 3591HEB
Device description
HEB Unifine Pentips pen needles, 6mm 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
00041220520336PrimaryGS10
00384703590007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00041220520336000412205203360412205203360041220520336
00384703590007003847035900073847035900070384703590007

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
Length6Millimeter
Needle Gauge31Gauge

Regulatory Flags#

DUNS number
007924756
Device count
50
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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