Catalog Number

-

Brand Name

FAST1

Version/Model Number

FAST1 Unit

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

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

d00e45b1-038b-49dd-93a1-6fc5c3f4c952

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 26, 2016

Package DI Number

30878353000012

Quantity per Package

50

Contains DI Package

10878353000018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-