Catalog Number

FASTR

Brand Name

ARROW

Version/Model Number

IPN038252

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

K180588,K180588

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

8a6bba9d-fcaa-4d2d-8259-f32969527c78

Public Version Date

October 25, 2019

Public Version Number

1

DI Record Publish Date

October 17, 2019

Package DI Number

44026704628689

Quantity per Package

10

Contains DI Package

24026704628685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multipack