Catalog Number

-

Brand Name

IMPROSAFE® Blood Collection Set

Version/Model Number

25G x 3/4” x 12”

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153388,K153388,K153388,K153388,K153388,K153388,K153388,K153388,K153388

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

16a41f0a-d495-4bcb-9fe5-d221685df679

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 20, 2022

Package DI Number

16974481830962

Quantity per Package

50

Contains DI Package

06974481830965

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-