Catalog Number

-

Brand Name

AHS

Version/Model Number

AH05M291340

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

fee4aa64-8f27-4406-84b6-d42da1f1ceac

Public Version Date

November 09, 2020

Public Version Number

4

DI Record Publish Date

March 31, 2016

Package DI Number

B031AH05M2913402

Quantity per Package

3600

Contains DI Package

B031AH05M2913401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton