Catalog Number

-

Brand Name

APOTECA

Version/Model Number

ADY1100C

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"

-

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

533aac01-40d5-4f0f-b86d-c1245cd6f93f

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-