FDA.reportPublic FDA data

Azur Medical Company Inc.

Primary DI
00860010450116
Brand
Azur Medical Company Inc.
Company
Azur Medical Company, Inc.
Model
CSB181H01
Published
2023-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K211214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211214000Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc.2021-10-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010450116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010450116008600104501168600104501160860010450116

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, non-filtering/non-ventedA slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117537693
Device count
1
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
00860010450109Azur Medical Company Inc. CS181012023-07-03
00860010450123Azur Medical Company Inc. CS251012023-07-03
00860010450130Azur Medical Company Inc. PS1K012023-07-03
00860010450147Azur Medical Company Inc. PS3K012023-07-03
00860010450154Azur Medical Company Inc. PS5K012023-07-03
00860010450161Azur Medical Company Inc. PCS12558K012023-07-03
00860010450178Azur Medical Company Inc. PCS3181K012023-07-03
00860010450185Azur Medical Company Inc. PCS52558K012023-07-03
00860010450192Azur Medical Company Inc. PCS10181K012023-07-03

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