Catalog Number

-

Brand Name

IMPROSAFE® Blood Collection Set

Version/Model Number

27G x 2/5” 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"

-

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

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

93ef28b5-1040-4906-a50c-9f952389a7dc

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 23, 2016

Package DI Number

46933395620275

Quantity per Package

20

Contains DI Package

16933395620274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-