Catalog Number

-

Brand Name

BAIXIN

Version/Model Number

3MLLL2315

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

K083686,K083686,K083686

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

b4bf0089-78df-42d3-a125-56af5ba38afc

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Package DI Number

16936018500267

Quantity per Package

2400

Contains DI Package

16936018500250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case