APOTECA - Transfer of liquid from a bag to syringes with - AEA SRL

Duns Number:429415227

Device Description: Transfer of liquid from a bag to syringes with APOTECAsyringe system

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More Product Details

Catalog Number

SDL-01-STD

Brand Name

APOTECA

Version/Model Number

S Dispensing Line

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

11c73b52-f3ad-4ef0-98db-9fbfc0089068

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AEA SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20