FDA.reportPublic FDA data

UltraFlo Insulin Syringe

Primary DI
B7442259421
Brand
UltraFlo Insulin Syringe
Company
QUALITY MEDICAL PRODUCTS USA, INC.
Model
225942
Device description
"1 ML 30GX1/2"""
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7442259422PackageHIBCC5In Commercial Distribution
B7442259423PackageHIBCC6In Commercial Distribution
B7442259421PrimaryHIBCC0
B7442259420Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Regulatory Flags#

DUNS number
054180248
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
B7442259313UltraFlo Insulin Syringe2259312019-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
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10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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