FDA.reportPublic FDA data

CODAN Luer-Lock 50-60 ml

Primary DI
05706225001321
Brand
CODAN Luer-Lock 50-60 ml
Company
Codan Medical ApS
Model
62.8426
Device description
CODAN Luer-Lock 50-60 ml, sterile, single-use, syringe
Published
2024-02-07
Public version status
New
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
K852444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852444000ASIK 'ONCE' SYRINGEPharma-Plast USA, Inc.1985-10-16FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05706225001321PrimaryGS10
05706225001307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05706225001321057062250013215706225001321
05706225001307057062250013075706225001307

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA 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 needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It 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.

Regulatory Flags#

DUNS number
310209432
Device count
300
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05706225000379CODAN Luer-Lock 2 ml62.26372024-04-24
05706225000492CODAN Luer-Lock 3 ml62.37602024-04-24
05706225001871CODAN Luer-Lock 2 ml62.26372024-04-24
05706225001918CODAN Luer-Lock 3 ml62.37602024-04-24
05706225000638CODAN Luer-Lock 5 ml62.47172024-02-07
05706225000966CODAN Luer-Lock 10 ml62.67062024-02-07
05706225001147CODAN Luer-Lock 20 ml62.77042024-02-07
05706225000614CODAN Luer-Lock 5 ml62.47172024-02-07
05706225000942CODAN Luer-Lock 10 ml62.67062024-02-07
05706225001123CODAN Luer-Lock 20 ml62.77042024-02-07
05706225001307CODAN Luer-Lock 50-60 ml62.84262024-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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