Catalog Number

-

Brand Name

APOTECA

Version/Model Number

ASN-05-B-NCE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K132011

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

ac4e753c-6ccc-4271-a8a9-a88933eda3ed

Public Version Date

March 24, 2022

Public Version Number

1

DI Record Publish Date

March 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-