FDA.reportPublic FDA data

UltraFlo Insulin Pen Needle

Primary DI
B7443357743
Brand
UltraFlo Insulin Pen Needle
Company
QUALITY MEDICAL PRODUCTS USA, INC.
Model
335774
Device description
32G X 5/32" (4mm)
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K133059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133059000INSULIN PEN NEEDLEWenzhou Beipu Science & Technology Co., Ltd.2014-02-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7443357742PackageHIBCC12In Commercial Distribution
B7443357743PackageHIBCC4In Commercial Distribution
B7443357741PrimaryHIBCC0
B7443357740Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054180248
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7442259311UltraFlo Insulin Syringe2259312019-06-24
B7442259321UltraFlo Insulin Syringe2259322019-06-24
B7442259331UltraFlo Insulin Syringe2259332019-06-24
B7442259341UltraFlo Insulin Syringe2259342019-06-24
B7442259351UltraFlo Insulin Syringe2259352019-06-24
B7442259361UltraFlo Insulin Syringe2259362019-06-24
B7442259371UltraFlo Insulin Syringe2259372019-06-24
B7442259381UltraFlo Insulin Syringe2259382019-06-24
B7442259391UltraFlo Insulin Syringe2259392019-06-24
B7442259401UltraFlo Insulin Syringe2259402019-06-24
B7442259411UltraFlo Insulin Syringe2259412019-06-24
B7442259421UltraFlo Insulin Syringe2259422019-06-24
B7442259431UltraFlo Insulin Syringe2259432019-06-24
B7442259441UltraFlo Insulin Syringe2259442019-06-24
B7442259451UltraFlo Insulin Syringe2259452019-06-24
B7443357711UltraFlo Insulin Pen Needle3357712019-06-24
B7443357721UltraFlo Insulin Pen Needle3357722019-06-24
B7443357731UltraFlo Insulin Pen Needle3357732019-06-24
B7443357741UltraFlo Insulin Pen Needle3357742019-06-24
B7443357761UltraFlo Insulin Pen Needle3357762019-06-24

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Primary DI, Brand, Company table
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08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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
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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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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