Catalog Number

-

Brand Name

APO-GO Syringe reservoir

Version/Model Number

APO-GO/20/WN

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

K052219

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

05ba5f43-bca7-42b8-96b4-47d1d8afbd05

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

May 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-