FDA.reportPublic FDA data

CDC - Premier Value - 31Gx8mm pen needles w/remover

Primary DI
00840986023682
Brand
CDC - Premier Value - 31Gx8mm pen needles w/remover
Company
PHARMACY VALUE ALLIANCE, LLC
Model
AN 3830CDC
Catalog number
AN 3830CDC
Device description
For use with injectors for the subcutaneous injection of approved drugs, including insulin
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
00761059831280PackageGS16Not in Commercial Distribution
00761059832287PackageGS124Not in Commercial Distribution
00840986023682PrimaryGS10
00384703830001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059831280007610598312807610598312800761059831280
00761059832287007610598322877610598322870761059832287
00840986023682008409860236828409860236820840986023682
00384703830001003847038300013847038300010384703830001

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
Length0
Needle Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
435-649-7251xx@xx.xx

Regulatory Flags#

DUNS number
089138159
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840986015854PREMIER VALUEF408-150CD2020-09-21
00840986016196Premier Value TamponsBPVAR402016-09-20
00840986016202Premier Value TamponsBPVAS402016-09-20
00840986016219Premier Value TamponsBPVAP402016-09-20
00840986016431PREMIER VALUE71091CD2020-09-21
00840986016516PREMIER VALUE67830CD2020-09-21
00840986016547PREMIER VALUE97205CD2020-09-21
00840986016639Premier ValueOne Step Pregnancy Test2016-08-30
00840986016646Premier ValueOne Step Pregnancy Test2016-08-30
00840986016684Premier Value Unilet LancetsAT 0575CDC2023-01-06
00840986021091Premier ValueEarly Result Pregnancy Test2016-08-30
00840986026850Premier Value TamponsBPVGS182016-09-20
00840986026867Premier Value TamponsBPVGC362016-09-20
00840986030123Premier Value30122017-06-23
00840986032837Premier Value Unilet LancetsAT 0585CDC2023-01-06
00840986034992Premier Value AutoletAT 0270CDC2023-02-03
00840986036781CDC- Premier Value- 33G x 4mm pen needles w/removerAN 3860CDCAN 3860CDC2021-05-25
00840986037009Premier ValueOne Step Pregnancy Test2020-09-21
00840986010095PREMIER93965HZ93965HZ2016-09-20
00840986023675CDC - Premier Value - 31Gx6mm pen needles w/removerAN 3890CDCAN 3890CDC2016-09-19

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Primary DI, Brand, Company table
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08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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