UltraFlo Insulin Syringe

Primary DI
B7442259373
Brand
UltraFlo Insulin Syringe
Company
QUALITY MEDICAL PRODUCTS USA, INC.
Model
225937
Device description
0.5 ML 29GX1/2"
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162180000Disposable Insulin SyringeBerpu Medical Technology Co., Ltd.2016-12-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7442259372PackageHIBCC5In Commercial Distribution
B7442259373PackageHIBCC6In Commercial Distribution
B7442259371PrimaryHIBCC0
B7442259370Unit 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.

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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