Azur Medical Company Inc.

Primary DI
00860010450185
Brand
Azur Medical Company Inc.
Company
Azur Medical Company, Inc.
Model
PCS52558K01
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211211000Sterile syringes for single use with/without needleAzur Medical Company, Inc.2021-10-07FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010450185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010450185008600104501858600104501850860010450185

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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
00860010450116Azur Medical Company Inc. CSB181H012023-07-03
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
00860010450192Azur Medical Company Inc. PCS10181K012023-07-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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