Catalog Number

MER 1923

Brand Name

BluWing

Version/Model Number

MER 1923

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

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

1ced7428-3bb4-4c65-a13a-33e696d87b20

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

July 01, 2017

Package DI Number

10850011007263

Quantity per Package

20

Contains DI Package

00850011007266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case